| NCT ID | NCT06338696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Transthyretin Amyloid Cardiomyopathy (ATTR-CM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 105 participants in total. It began in 2024-07-30 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Rungroj Krittayaphong, MD, FESC, FACC
PRINCIPAL INVESTIGATOR
Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University
Frequently Asked Questions
Who can join the NCT06338696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06338696 currently recruiting?
Yes, NCT06338696 is actively recruiting participants. Contact the research team at kanchalaporn.jir@mahidol.ac.th for enrollment information.
Where is the NCT06338696 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Bangkok, Thailand, Bangkok, Thailand, Bangkok, Thailand and 4 additional locations.
Who is sponsoring the NCT06338696 clinical trial?
NCT06338696 is sponsored by Mahidol University. The principal investigator is Rungroj Krittayaphong, MD, FESC, FACC at Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University. The trial plans to enroll 105 participants.