Thailand ATTR-CM Registry

Recruiting

• Conditions: Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
• Interventions: Other: No intervention

• Registration Number: NCT06338696
• Lead Sponsor: Mahidol University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-01
• Study Start: 2024-07-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2029-06-01
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ATTR Cardiomyopathy	No intervention	Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy)

Primary Outcome Measures

Name	Time	Method
Rate of heart failure hospitalization	3 years
Rate of death	3 years

Secondary Outcome Measures

Name	Time	Method
Transthyretin (ATTR) amyloidosis medication	3 years	Rate of use and rate of adverse effect of Transthyretin (ATTR) amyloidosis medication

Trial Locations

Locations (8)

Faculty of Medicine at Chulalongkorn University; 🇹🇭 Bangkok, Thailand

Faculty of Medicine Ramathibodi hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand

Faculty of Medicine Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

Queen Sirikit Heart Center of The Northeast; 🇹🇭 Khon Kaen, Thailand

Faculty of Medicine, Thammasat University; 🇹🇭 Pathum Thani, Thailand

Prince of Songkla University; 🇹🇭 Songkhla, Thailand