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NCT Number: NCT06338696

Thailand ATTR-CM Registry

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.

Recruiting

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Key information

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Cardiomyopathies Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Ramathibodi hospital, Mahidol University, Bangkok, Thailand

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Rate of death

    Time frame: 3 years

  2. Rate of heart failure hospitalization

    Time frame: 3 years

Secondary outcomes

  1. Transthyretin (ATTR) amyloidosis medication

    Time frame: 3 years

    Rate of use and rate of adverse effect of Transthyretin (ATTR) amyloidosis medication

Study contacts

Contact information is provided by the study sponsor or research team.

Kanchalaporn Jirataiporn, B.N.S.

CONTACT

[email protected]

0635153519

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Pfizer

Registry information

Official study title

Thailand Transthyretin Amyloid Cardiomyopathy Registry

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Apr 1, 2024
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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