Trial Outcomes & Findings for Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology (NCT NCT03842163)

Results Overview

Percentage of participants with cardiac fixation on a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD or 99mTc-PYP or 999mTc-HMDP among participants with LVH from an undiagnosed etiology were reported in this outcome measure. Scintigraphy was defined at each bone site according to the standard grading: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone.

Recruitment status

COMPLETED

Target enrollment

812 participants

Primary outcome timeframe

During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Results posted on

2024-02-12

Participant Flow

Data of participants diagnosed with left ventricular hypertrophy (LVH) confirmed by bone scintigraphy and/or single photon emission computed tomography (SPECT) and greater than or equal to (\>=) 50 years of age were observed in this study.

Data from eligible participants were retrieved and observed from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years).

Participant milestones

Participant milestones
Measure	All Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Overall Study STARTED	812
Overall Study Full Analysis Set 1	766
Overall Study Full Analysis Set 2 (Subset of FAS 1)	245
Overall Study Full Analysis Set 3 (Subset of FAS 2)	208
Overall Study Full Analysis Set 3.1	137
Overall Study Full Analysis Set 3.2	56
Overall Study COMPLETED	766
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Overall Study Did not meet inclusion criteria (age less than 50 years)	2
Overall Study Scintigraphy was not performed	44

Baseline Characteristics

Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=766 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Age, Continuous	72.3 Years STANDARD_DEVIATION 10.6 • n=93 Participants
Sex: Female, Male Female	233 Participants n=93 Participants
Sex: Female, Male Male	533 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	665 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian & Portuguese (or Portuguese parents)	47 Participants n=93 Participants
Race/Ethnicity, Customized African	21 Participants n=93 Participants
Race/Ethnicity, Customized Asian	27 Participants n=93 Participants
Race/Ethnicity, Customized Other	6 Participants n=93 Participants

PRIMARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.

Percentage of participants with cardiac fixation on a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD or 99mTc-PYP or 999mTc-HMDP among participants with LVH from an undiagnosed etiology were reported in this outcome measure. Scintigraphy was defined at each bone site according to the standard grading: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone.

Outcome measures

Outcome measures
Measure	All Participants n=766 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1	32.0 Percentage of participants Interval 28.8 to 35.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.

Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.

Outcome measures

Outcome measures
Measure	All Participants n=766 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1	17.9 Percentage of participants Interval 15.3 to 20.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.

Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.

Outcome measures

Outcome measures
Measure	All Participants n=766 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1	25.2 Percentage of participants Interval 22.3 to 28.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2)	6.5 Percentage of participants Interval 3.8 to 10.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3)	6.9 Percentage of participants Interval 4.1 to 11.5

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1	8.7 Percentage of participants Interval 4.9 to 14.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2	3.7 Percentage of participants Interval 1.0 to 12.5

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2	93.5 Percentage of participants Interval 89.2 to 96.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3	93.1 Percentage of participants Interval 88.5 to 95.9

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1	91.3 Percentage of participants Interval 85.2 to 95.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2	96.3 Percentage of participants Interval 87.5 to 99.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=200 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2	13 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3	13 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=127 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1	11 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants With TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=54 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2	2 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.

Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a left ventricular (LV) wall thickness greater than or equal to (\>=) 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.

Outcome measures

Outcome measures
Measure	All Participants n=766 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 1	17.1 Percentage of participants Interval 14.6 to 19.9

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 2	11.8 Percentage of participants Interval 8.4 to 16.5

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3	9.6 Percentage of participants Interval 6.3 to 14.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.1	10.9 Percentage of participants Interval 6.7 to 17.3

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness \>= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.2	7.1 Percentage of participants Interval 2.8 to 17.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags Electronic Case Report Form (e-CRF) part was considered as participants with a senso-motor polyneuropathy.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2	80.0 Percentage of participants Interval 74.5 to 84.5

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3	86.1 Percentage of participants Interval 80.7 to 90.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1	89.8 Percentage of participants Interval 83.6 to 93.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2	85.7 Percentage of participants Interval 74.3 to 92.6

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2	48.6 Percentage of participants Interval 42.4 to 54.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3	54.8 Percentage of participants Interval 48.0 to 61.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1	60.6 Percentage of participants Interval 52.2 to 68.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2	48.2 Percentage of participants Interval 35.7 to 61.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Autonomic Dysfunction: FAS 2	55.9 Percentage of participants Interval 49.7 to 62.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Autonomic Dysfunction: FAS 3	58.7 Percentage of participants Interval 51.9 to 65.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Autonomic Dysfunction: FAS 3.1	61.3 Percentage of participants Interval 53.0 to 69.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Autonomic Dysfunction: FAS 3.2	57.1 Percentage of participants Interval 44.1 to 69.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval less than (\<) 80 milliseconds (ms) or greater than (\>) 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Cardiological Manifestations: FAS 2	98.0 Percentage of participants Interval 95.3 to 99.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Cardiological Manifestations: FAS 3	98.1 Percentage of participants Interval 95.2 to 99.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Cardiological Manifestations: FAS 3.1	97.8 Percentage of participants Interval 93.8 to 99.3

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval \< 80 ms or \> 350 ms QRS interval \< 60 ms or \> 250 ms, Sokolow index \< 1 mm or \> 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter \<20 mm or \>80 mm, MWT \<15 mm or \>100 mm, MWT at septum \<3 mm or \>50 mm, MWT posterior wall \<3 mm or \>50 mm, LV mass index \<40 g/m\^2 or \>160 g/m\^2, Maximal aortic velocity \>5 m/s, Mean gradient of Aortic valvular stenosis \>70 mmHg, Area of Aortic valvular stenosis \<0.2 cm\^2 or \>3 cm\^2.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Cardiological Manifestations: FAS 3.2	98.2 Percentage of participants Interval 90.6 to 99.7

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Laboratory parameters that were considered as out of range included creatinine \<45 micromole per liter (μmol/L) or greater than 104 μmol/L w; haemoglobin, participants with a value lower than 11.5 grams per deciliter (g/dL) or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 picograms per milliliter (pg/mL); N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Laboratory Abnormalities: FAS 2 Creatinine out of range	37.6 Percentage of participants Interval 31.7 to 43.8
Percentage of Participants With Laboratory Abnormalities: FAS 2 Haemoglobin out of range	30.2 Percentage of participants Interval 24.8 to 36.2
Percentage of Participants With Laboratory Abnormalities: FAS 2 BNP out of range	62.9 Percentage of participants Interval 56.7 to 68.7
Percentage of Participants With Laboratory Abnormalities: FAS 2 NTproBNP out of range	81.2 Percentage of participants Interval 75.9 to 85.6
Percentage of Participants With Laboratory Abnormalities: FAS 2 Troponin I out of range	3.7 Percentage of participants Interval 1.9 to 6.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Laboratory Abnormalities: FAS 3 Creatinine out of range	42.3 Percentage of participants Interval 35.8 to 49.1
Percentage of Participants With Laboratory Abnormalities: FAS 3 Haemoglobin out of range	33.2 Percentage of participants Interval 27.1 to 39.8
Percentage of Participants With Laboratory Abnormalities: FAS 3 BNP out of range	69.7 Percentage of participants Interval 63.2 to 75.6
Percentage of Participants With Laboratory Abnormalities: FAS 3 NTproBNP out of range	88.9 Percentage of participants Interval 84.0 to 92.5
Percentage of Participants With Laboratory Abnormalities: FAS 3 Troponin I out of range	3.8 Percentage of participants Interval 2.0 to 7.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Laboratory Abnormalities: FAS 3.1 Creatinine out of range	34.3 Percentage of participants Interval 26.9 to 42.6
Percentage of Participants With Laboratory Abnormalities: FAS 3.1 Haemoglobin out of range	34.3 Percentage of participants Interval 26.9 to 42.6
Percentage of Participants With Laboratory Abnormalities: FAS 3.1 BNP out of range	68.6 Percentage of participants Interval 60.4 to 75.8
Percentage of Participants With Laboratory Abnormalities: FAS 3.1 NTproBNP out of range	90.5 Percentage of participants Interval 84.4 to 94.4
Percentage of Participants With Laboratory Abnormalities: FAS 3.1 Troponin I out of range	4.4 Percentage of participants Interval 2.0 to 9.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Laboratory parameters that were considered as out of range included creatinine \<45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Percentage of Participants With Laboratory Abnormalities: FAS 3.2 Creatinine out of range	58.9 Percentage of participants Interval 45.9 to 70.8
Percentage of Participants With Laboratory Abnormalities: FAS 3.2 Haemoglobin out of range	35.7 Percentage of participants Interval 24.5 to 48.8
Percentage of Participants With Laboratory Abnormalities: FAS 3.2 BNP out of range	89.3 Percentage of participants Interval 78.5 to 95.0
Percentage of Participants With Laboratory Abnormalities: FAS 3.2 NTproBNP out of range	98.2 Percentage of participants Interval 90.6 to 99.7
Percentage of Participants With Laboratory Abnormalities: FAS 3.2 Troponin I out of range	1.8 Percentage of participants Interval 0.3 to 9.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP.

Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.

Outcome measures

Outcome measures
Measure	All Participants n=766 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Presence of Neurological Red Flag: FAS1 Yes	143 Participants
Number of Participants According to Presence of Neurological Red Flag: FAS1 No	623 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Presence of Neurological Red Flag: FAS 2 Yes	142 Participants
Number of Participants According to Presence of Neurological Red Flag: FAS 2 No	103 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS1 included all participants who met eligibility criteria and with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Grade of scintigraphy evaluated by the investigator and Grade of SPECT: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone. Only categories with non-zero values were reported.

Outcome measures

Outcome measures
Measure	All Participants n=75 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 Investigator: Grade 0; SPECT: Grade 0	43 Participants
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 Investigator: Grade 0; SPECT: Grade 1	3 Participants
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 Investigator: Grade 1; SPECT: Grade 1	5 Participants
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 Investigator: Grade 2; SPECT: Grade 2	16 Participants
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 Investigator: Grade 3; SPECT: Grade 3	8 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated.

Outcome measures

Outcome measures
Measure	All Participants n=238 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Cardiological Assessments - Blood Pressure: FAS 2 DBP	75.6 mmHg Standard Deviation 12.4
Cardiological Assessments - Blood Pressure: FAS 2 SBP	132.5 mmHg Standard Deviation 20.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

SBP and DBP were evaluated.

Outcome measures

Outcome measures
Measure	All Participants n=203 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Cardiological Assessments - Blood Pressure: FAS 3 DBP	74.6 mmHg Standard Deviation 12.0
Cardiological Assessments - Blood Pressure: FAS 3 SBP	131.0 mmHg Standard Deviation 19.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

SBP and DBP were evaluated.

Outcome measures

Outcome measures
Measure	All Participants n=133 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Cardiological Assessments - Blood Pressure: FAS 3.1 DBP	75.6 mmHg Standard Deviation 11.8
Cardiological Assessments - Blood Pressure: FAS 3.1 SBP	130.9 mmHg Standard Deviation 18.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

SBP and DBP were evaluated.

Outcome measures

Outcome measures
Measure	All Participants n=55 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Cardiological Assessments - Blood Pressure: FAS 3.2 DBP	74.2 mmHg Standard Deviation 11.9
Cardiological Assessments - Blood Pressure: FAS 3.2 SBP	131.9 mmHg Standard Deviation 20.5

SECONDARY outcome

Timeframe: Baseline

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Diagnosed hypertension · No	78 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Diagnosed hypertension · Yes	167 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Antihypertensive medication · No	89 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Antihypertensive medication · Yes	156 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Coronary artery disease · No	184 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Coronary artery disease · Yes	61 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Renal insufficiency · No	177 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Renal insufficiency · Yes	68 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Diabetes Mellitus · No	193 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Diabetes Mellitus · Yes	52 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Lumbar spinal stenosis · No	221 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Lumbar spinal stenosis · Yes	24 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Carpal tunnel syndrome · No	164 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 Carpal tunnel syndrome · Yes	81 Participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Diagnosed hypertension · No	77 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Diagnosed hypertension · Yes	131 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Antihypertensive medication · No	88 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Antihypertensive medication · Yes	120 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Coronary artery disease · No	162 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Coronary artery disease · Yes	46 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Renal insufficiency · No	147 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Renal insufficiency · Yes	61 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Diabetes Mellitus · No	175 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Diabetes Mellitus · Yes	33 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Lumbar spinal stenosis · No	184 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Lumbar spinal stenosis · Yes	24 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Carpal tunnel syndrome · No	130 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 Carpal tunnel syndrome · Yes	78 Participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Diagnosed hypertension · No	49 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Diagnosed hypertension · Yes	88 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Antihypertensive medication · No	57 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Antihypertensive medication · Yes	80 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Coronary artery disease · No	112 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Coronary artery disease · Yes	25 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Renal insufficiency · No	102 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Renal insufficiency · Yes	35 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Diabetes Mellitus · No	118 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Diabetes Mellitus · Yes	19 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Lumbar spinal stenosis · No	121 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Lumbar spinal stenosis · Yes	16 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Carpal tunnel syndrome · No	80 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 Carpal tunnel syndrome · Yes	57 Participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Lumbar spinal stenosis · No	50 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Diagnosed hypertension · No	19 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Diagnosed hypertension · Yes	37 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Antihypertensive medication · No	22 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Antihypertensive medication · Yes	34 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Coronary artery disease · No	43 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Coronary artery disease · Yes	13 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Renal insufficiency · No	35 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Renal insufficiency · Yes	21 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Diabetes Mellitus · No	45 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Diabetes Mellitus · Yes	11 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Lumbar spinal stenosis · Yes	6 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Carpal tunnel syndrome · No	37 Participants
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 Carpal tunnel syndrome · Yes	19 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 Class I	50 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 Class II	130 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 Class III	57 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 Class IV	7 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 Missing data	1 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 Class I	45 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 Class II	112 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 Class III	45 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 Class IV	5 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 Missing data	1 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 Class I	34 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 Class II	69 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 Class III	30 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 Class IV	3 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 Missing data	1 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 Class I	5 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 Class II	38 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 Class III	11 Participants
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 Class IV	2 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Atrial Fibrillation Assessment: FAS 2 No	120 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 2 Yes permanent	90 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 2 Yes in the past	35 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Atrial Fibrillation Assessment: FAS 3 No	105 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 3 Yes permanent	78 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 3 Yes in the past	25 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 No	65 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 Yes permanent	52 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 Yes in the past	20 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 No	28 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 Yes permanent	23 Participants
Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 Yes in the past	5 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3.

Participants who used pacemaker and ICD were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=245 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 Pacemaker · Yes	30 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 Pacemaker · No	215 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 ICD · Yes	0 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 ICD · No	245 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3.

Participants who used pacemaker and ICD were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=208 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 Pacemaker · Yes	30 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 Pacemaker · No	178 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 ICD · Yes	0 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 ICD · No	208 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis).

Participants who used pacemaker and ICD were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=137 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 Pacemaker · Yes	20 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 Pacemaker · No	117 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 ICD · Yes	0 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 ICD · No	137 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Participants who used pacemaker and ICD were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 Pacemaker · Yes	7 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 Pacemaker · No	49 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 ICD · Yes	0 Participants
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 ICD · No	56 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.

Outcome measures

Outcome measures
Measure	All Participants n=66 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2 Negative	11 Participants
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2 Positive	55 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.

Outcome measures

Outcome measures
Measure	All Participants n=57 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3 Negative	7 Participants
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3 Positive	50 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.

Outcome measures

Outcome measures
Measure	All Participants n=39 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1 Negative	6 Participants
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1 Positive	33 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.

Outcome measures

Outcome measures
Measure	All Participants n=13 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2 Negative	0 Participants
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2 Positive	13 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=235 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2 No	217 Participants
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2 Yes	18 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=200 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3 No	182 Participants
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3 Yes	18 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=132 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1 No	122 Participants
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1 Yes	10 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=55 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2 No	49 Participants
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2 Yes	6 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=214 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Heart Rate Parameter for Participants Without Paced: FAS 2	73.3 Beats per minute Standard Deviation 15.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=179 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Heart Rate Parameter for Participants Without Paced: FAS 3	73.2 Beats per minute Standard Deviation 14.7

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=121 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Heart Rate Parameter for Participants Without Paced: FAS 3.1	73.4 Beats per minute Standard Deviation 15.9

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=48 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Heart Rate Parameter for Participants Without Paced: FAS 3.2	72.7 Beats per minute Standard Deviation 12.1

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=227 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 No	86 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 Yes	135 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 Missing	6 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=190 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 No	72 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 Yes	114 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 Missing	4 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=127 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 No	51 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 Yes	73 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 Missing	3 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=50 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 No	18 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 Yes	32 Participants
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 Missing	0 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.

Outcome measures

Outcome measures
Measure	All Participants n=180 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Sokolow Index: FAS 2	19.1 Millimeter Standard Deviation 8.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.

Outcome measures

Outcome measures
Measure	All Participants n=148 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Sokolow Index: FAS 3	18.7 Millimeter Standard Deviation 8.6

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.

Outcome measures

Outcome measures
Measure	All Participants n=103 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Sokolow Index: FAS 3.1	19.8 Millimeter Standard Deviation 8.7

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.

Outcome measures

Outcome measures
Measure	All Participants n=39 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Sokolow Index: FAS 3.2	16.5 Millimeter Standard Deviation 8.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.

Outcome measures

Outcome measures
Measure	All Participants n=241 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Left Ventricular Ejection Fraction (LVEF): FAS 2	55.0 Percentage of blood volume Standard Deviation 11.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.

Outcome measures

Outcome measures
Measure	All Participants n=205 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Left Ventricular Ejection Fraction (LVEF): FAS 3	55.2 Percentage of blood volume Standard Deviation 11.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.

Outcome measures

Outcome measures
Measure	All Participants n=134 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Left Ventricular Ejection Fraction (LVEF): FAS 3.1	55.7 Percentage of blood volume Standard Deviation 11.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Left Ventricular Ejection Fraction (LVEF): FAS 3.2	53.9 Percentage of blood volume Standard Deviation 11.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.

Outcome measures

Outcome measures
Measure	All Participants n=241 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2 No	215 Participants
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2 Yes	26 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.

Outcome measures

Outcome measures
Measure	All Participants n=205 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3 No	183 Participants
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3 Yes	22 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.

Outcome measures

Outcome measures
Measure	All Participants n=136 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1 No	119 Participants
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1 Yes	17 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2 No	51 Participants
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2 Yes	5 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants were classified according to strain apical preserved as 'No' and 'Yes'.

Outcome measures

Outcome measures
Measure	All Participants n=90 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2 No	28 Participants
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2 Yes	62 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants were classified according to strain apical preserved as 'No' and 'Yes'.

Outcome measures

Outcome measures
Measure	All Participants n=86 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3 No	26 Participants
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3 Yes	60 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants were classified according to strain apical preserved as 'No' and 'Yes'.

Outcome measures

Outcome measures
Measure	All Participants n=62 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1 No	16 Participants
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1 Yes	46 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants were classified according to strain apical preserved as 'No' and 'Yes'.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2 No	8 Participants
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2 Yes	12 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Left ventricular end-diastolic diameter (LVEDD) reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.

Outcome measures

Outcome measures
Measure	All Participants n=218 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV End Diastolic Diameter: FAS 2	43.3 Millimeter Standard Deviation 7.9

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.

Outcome measures

Outcome measures
Measure	All Participants n=182 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV End Diastolic Diameter: FAS 3	43.2 Millimeter Standard Deviation 7.9

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.

Outcome measures

Outcome measures
Measure	All Participants n=120 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV End Diastolic Diameter: FAS 3.1	43.2 Millimeter Standard Deviation 7.5

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.

Outcome measures

Outcome measures
Measure	All Participants n=50 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV End Diastolic Diameter: FAS 3.2	44.4 Millimeter Standard Deviation 6.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=240 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Maximum Wall Thickness: FAS 2	17.4 Millimeter Standard Deviation 2.5

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=204 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Maximum Wall Thickness: FAS 3	17.5 Millimeter Standard Deviation 2.4

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=136 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Maximum Wall Thickness: FAS 3.1	17.9 Millimeter Standard Deviation 2.5

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Maximum Wall Thickness: FAS 3.2	16.9 Millimeter Standard Deviation 2.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.

Outcome measures

Outcome measures
Measure	All Participants n=240 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Type of Hypertrophic Pattern: FAS 2 Apical	6 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 2 Concentric	179 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 2 Asymmetric	47 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 2 Mix	8 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.

Outcome measures

Outcome measures
Measure	All Participants n=204 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Type of Hypertrophic Pattern: FAS 3 Apical	4 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3 Concentric	159 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3 Asymmetric	37 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3 Mix	4 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.

Outcome measures

Outcome measures
Measure	All Participants n=135 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 Apical	1 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 Concentric	105 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 Asymmetric	27 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 Mix	2 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.

Outcome measures

Outcome measures
Measure	All Participants n=56 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 Apical	2 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 Concentric	46 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 Asymmetric	7 Participants
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 Mix	1 Participants

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.

Outcome measures

Outcome measures
Measure	All Participants n=146 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV Mass Index (LVMI): FAS 2	172.7 Grams per meter square Standard Deviation 64.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.

Outcome measures

Outcome measures
Measure	All Participants n=115 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV Mass Index (LVMI): FAS 3	177.0 Grams per meter square Standard Deviation 53.2

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.

Outcome measures

Outcome measures
Measure	All Participants n=75 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV Mass Index (LVMI): FAS 3.1	177.0 Grams per meter square Standard Deviation 48.7

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis).

Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.

Outcome measures

Outcome measures
Measure	All Participants n=31 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
LV Mass Index (LVMI): FAS 3.2	185.5 Grams per meter square Standard Deviation 62.0

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 2 included all eligible participants with a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 1, grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=146 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Aortic Valvular Stenosis - Aortic Valve Area: FAS 2	2.3 Centimeter square Standard Deviation 0.8

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3 included all eligible participants with radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD/99mTc-PYP/99mTc-HMDP and with grading of cardiac retention equal to grade 2 or grade 3. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=123 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3	2.2 Centimeter square Standard Deviation 0.7

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.1 included all eligible participants with grade 2-3 without monoclonal protein abnormalities (ATTR amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=83 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1	2.3 Centimeter square Standard Deviation 0.7

SECONDARY outcome

Timeframe: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Population: FAS 3.2 included all eligible participants with grade 2-3 with monoclonal protein abnormalities (undefined etiology, cardiac ATTR amyloidosis, or MGUS or AL amyloidosis). Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=34 Participants Participants diagnosed with LVH of unknown etiology confirmed by bone scintigraphy and/or SPECT were included.
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2	2.0 Centimeter square Standard Deviation 0.7

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER