NCT06338696Recruiting
Thailand ATTR-CM Registry
Thailand Transthyretin Amyloid Cardiomyopathy Registry
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 105 (estimated)
- First submitted
- 14 Mar 2024
- Start date
- Jul 2024
- Primary completion date
- Jun 2029
- Lead sponsor
- Mahidol University
- Diseases
- Amyloidosis, Heart failure
- NCT number
- NCT06338696
What you commit to
- Study type: Observational
- Planned participants: 105
- From Jul 2024 to the primary completion date, Jun 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)
- Diagnosed with secondary amyloidosis
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Faculty of Medicine at Chulalongkorn University Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Phramongkutklao Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Faculty of Medicine, Ramathibodi Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Faculty of Medicine, Chiang Mai University Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Not yet recruiting |
| Queen Sirikit Heart Center of The Northeast Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Not yet recruiting |
| Faculty of Medicine, Thammasat University Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Not yet recruiting |
| Prince of Songkla University Coordinator of this site? Confirm its status | Songkhla | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.