Thailand ATTR-CM Registry

Last updated: May 5, 2025
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Circulation Disorders

Treatment

No intervention

Clinical Study ID

NCT06338696
COA-CREC070/2023
  • Ages 18-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Age > 18 years.

  • All patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy) who have eithersymptomatic or asymptomatic must have evidence of cardiac involvement byechocardiogram as defined by left ventricle wall thickness of ≥ 12 mm and with atleast one of the following criteria:

  • Positive scintigraphy by 99mTC-DPD [99mTC-3,3-diphosphono-1,2-propano-dicarboxylicacid] or 99mTC-PYP [Pyrophosphate] or 99mTC-HMDP [hydroxymethylene diphosphate] withPerugini 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-dicarboxylicacid] or 99mTC-PYP [Pyrophosphate] or 99mTC-HMDP [hydroxymethylene diphosphate] withPerugini 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-dicarboxylicacid] or 99mTC-PYP [Pyrophosphate] or 99mTC-HMDP [hydroxymethylene diphosphate] withPerugini grade 1 with positive non-cardiac biopsy tissue confirmed by Congo redstain

  • 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

Exclusion Criteria:

  • Diagnosed with amyloidosis caused by proteins other than transthyretin (light chainAmyloidosis, etc.)

  • Diagnosed with secondary amyloidosis

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
July 30, 2024
Estimated Completion Date:
June 30, 2030

Connect with a study center

  • Faculty of Medicine Ramathibodi hospital, Mahidol University

    Bangkok,
    Thailand

    Site Not Available

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok,
    Thailand

    Site Not Available

  • Faculty of Medicine at Chulalongkorn University

    Bangkok,
    Thailand

    Site Not Available

  • Phramongkutklao Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Faculty of Medicine Chiang Mai University

    Chiang Mai,
    Thailand

    Site Not Available

  • Queen Sirikit Heart Center of The Northeast

    Khon Kaen,
    Thailand

    Site Not Available

  • Faculty of Medicine, Thammasat University

    Pathum Thani,
    Thailand

    Site Not Available

  • Prince of Songkla University

    Songkhla,
    Thailand

    Active - Recruiting

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