Thailand ATTR-CM Registry

NCT ID: NCT06338696

Last Updated: 2025-05-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-30

Study Completion Date

2030-06-30

Brief Summary

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The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand.

Detailed Description

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Conditions

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Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ATTR Cardiomyopathy

Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years.
* All patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy) who have either symptomatic or asymptomatic must have evidence of cardiac involvement by echocardiogram as defined by left ventricle wall thickness of ≥ 12 mm and with at least one of the following criteria:
* Positive scintigraphy by 99mTC-DPD \[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\] or 99mTC-PYP \[Pyrophosphate\] or 99mTC-HMDP \[hydroxymethylene diphosphate\] with Perugini grade ≥ 2 and/or H/CL (heart to contralateral lung) ratio \> 1.5
* Positive scintigraphy by 99mTC-DPD \[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\] or 99mTC-PYP \[Pyrophosphate\] or 99mTC-HMDP \[hydroxymethylene diphosphate\] with Perugini grade 1 and positive cardiac biopsy tissue confirmed which Congo red stain ≥ 4 sites
* Positive scintigraphy by 99mTC-DPD \[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\] or 99mTC-PYP \[Pyrophosphate\] or 99mTC-HMDP \[hydroxymethylene diphosphate\] with Perugini grade 1 with positive non-cardiac biopsy tissue confirmed by Congo red stain
* Abnormalities on CMR (Cardiac MRI) \[Subendocardium LGE (late gadolinium enhancement) and/or elevated native T1 value and/or increased extracellular volume (ECV \> 0.4)\] with positive non-cardiac and/or cardiac tissue biopsy confirmed by Congo red stain

Exclusion Criteria

* Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)
* Diagnosed with secondary amyloidosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Rungroj Krittayaphong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rungroj Krittayaphong, MD, FESC, FACC

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University

Locations

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Faculty of Medicine at Chulalongkorn University

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine Ramathibodi hospital, Mahidol University

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine Chiang Mai University

Chiang Mai, , Thailand

Site Status NOT_YET_RECRUITING

Queen Sirikit Heart Center of The Northeast

Khon Kaen, , Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine, Thammasat University

Pathum Thani, , Thailand

Site Status NOT_YET_RECRUITING

Prince of Songkla University

Songkhla, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Kanchalaporn Jirataiporn, B.N.S.

Role: CONTACT

0635153519

Facility Contacts

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Sarinya Puwanant, MD

Role: primary

Teerapat Yingchoncharoen, MD

Role: primary

Kanchalaporn Jirataiporn, B.N.S

Role: primary

Hutsaya Prasitdumrong, MD

Role: primary

Arintaya Phrommintikul, MD

Role: primary

Vichai Senthong, MD

Role: primary

Adisai Buakhamsri, MD

Role: primary

Thammarak Songsangjinda, MD

Role: primary

Other Identifiers

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COA-CREC070/2023

Identifier Type: -

Identifier Source: org_study_id

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