Registry for studying Transthyretin Amyloid Cardiomyopathy in Thailand
Thailand Transthyretin Amyloid Cardiomyopathy Registry
This study is collecting information from people with Transthyretin Amyloid Cardiomyopathy in Thailand to better understand the disease and improve early detection and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 8 sites (Bangkok and 7 other locations) |
| Trial ID | NCT06338696 on ClinicalTrials.gov |
What this trial studies
This registry aims to longitudinally study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in Thailand. By collecting detailed data on both symptomatic and asymptomatic patients, the investigators hope to enhance understanding of the disease and develop early screening programs for at-risk individuals. The findings will also support epidemiological studies and raise awareness among healthcare providers about this condition, especially as amyloid-specific therapies become available in the region.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults over 18 years diagnosed with ATTR-CM who show evidence of cardiac involvement.
Not a fit: Patients without a confirmed diagnosis of ATTR-CM or those under 18 years old may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved early detection and management of ATTR-CM, ultimately enhancing patient outcomes.
How similar studies have performed: While this registry approach is not novel, it builds on previous successful observational studies that have enhanced understanding of similar conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok and 7 other locations
- Faculty of Medicine at Chulalongkorn University — Bangkok, Thailand (Not_yet_recruiting)
- Faculty of Medicine Ramathibodi hospital, Mahidol University — Bangkok, Thailand (Not_yet_recruiting)
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand (Not_yet_recruiting)
- Phramongkutklao Hospital — Bangkok, Thailand (Not_yet_recruiting)
- Faculty of Medicine Chiang Mai University — Chiang Mai, Thailand (Not_yet_recruiting)
- Queen Sirikit Heart Center of The Northeast — Khon Kaen, Thailand (Not_yet_recruiting)
- Faculty of Medicine, Thammasat University — Pathum Thani, Thailand (Not_yet_recruiting)
- Prince of Songkla University — Songkhla, Thailand (Recruiting)
Study contacts
- Principal investigator: Rungroj Krittayaphong, MD, FESC, FACC — Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University
- Study coordinator: Kanchalaporn Jirataiporn, B.N.S.
- Email: kanchalaporn.jir@mahidol.ac.th
- Phone: 0635153519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.