Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
NCT ID: NCT05577819
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
515 participants
INTERVENTIONAL
2020-10-02
2026-12-31
Brief Summary
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Detailed Description
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During the single study visit the following will be obtained:
* 99mTc-pyrophosphate SPECT scan
* Blood and DNA (optional) sample collection
* Questionnaires in regards to neuropathy, carpal tunnel, frailty, and Heart failure symptoms and how they may affect ones quality of life
* 6-Minute Walk Test
* ECG (electrocardiogram)
* Echocardiogram
Electronic health records will be reviewed for up to 5 years in order to determine hospitalization and survival of the study participants. Clinical outcomes of interest include a combined endpoint of days alive outside of the hospital from heart failure hospitalizations at one and five years, presence of autonomic neuropathy, presence of carpal tunnel syndrome, presence of polyneuropathy. Additionally, Individual clinical endpoints are also endpoints of interest.
The results from this study will be used to determine how frequently heart failure patients have transthyretin amyloidosis in their heart and better understand their symptoms. We hope that better understanding transthyretin amyloidosis in heart failure patients will help us identify affected patients so that they can receive treatment.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients 65 and older with Heart Failure with Preserved Ejection Fraction
Patients 65 years and older presenting to Massachusetts General Hospital with a known diagnosis of HFpEF and without a diagnosis of amyloidosis in the ambulatory (outpatient) setting will undergo a 99Tc-Pyrophosphate Scan to identify Cardiac Amyloidosis
99mTc-pyrophosphate Scintigraphy
Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer
Interventions
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99mTc-pyrophosphate Scintigraphy
Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥65 years old
Exclusion Criteria
* no history of HFrEF (LVEF\<40%) with the exception of low LVEF in the setting of acute decompensation, AF RVR, ACS/MI, etc
* Negative 99mTc-pyrophosphate scan within a year
* Unable to lie down for 15 minutes for the 99mTc-pyrophosphate scan
* Known diagnosis of amyloidosis
* Severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)
65 Years
ALL
No
Sponsors
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Akcea Therapeutics
INDUSTRY
Pfizer
INDUSTRY
Alnylam Pharmaceuticals
INDUSTRY
Eidos Therapeutics, a BridgeBio company
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Hanna Kim Gaggin
Principal Investigator, Associate Professor of Medicine
Principal Investigators
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Hanna K Gaggin, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Heather Jameson, PhD
Role: primary
Other Identifiers
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2020P002061
Identifier Type: -
Identifier Source: org_study_id