ClinicalTrials.gov record NCT06338696

Thailand ATTR-CM Registry

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Thailand Transthyretin Amyloid Cardiomyopathy Registry

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 100 years old
SexAll
LocationThailand
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational registry that follows adults diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM), whether symptomatic or not. It records clinical presentation, imaging findings, treatments, and outcomes over time. The registry seeks to describe the disease course and patterns of care in Thailand.

What it is studying. The study aims to describe the natural history, clinical features, and imaging characteristics of ATTR-CM in Thailand, and to record outcomes such as death and heart-failure hospitalization and the use and adverse effects of ATTR medications.

What the researchers hope to learn. To improve understanding of ATTR-CM in Thailand by documenting its natural history, clinical and imaging features, treatment use and adverse effects, and outcomes; to inform early screening efforts, raise awareness among non-cardiologists, and support epidemiological studies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • No intervention

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an observational registry with no study treatment: investigators will collect and follow clinical information and test results over time. Collected data may include medical history, hospitalizations, deaths, use of ATTR medications and their adverse effects, and existing imaging or biopsy results (echocardiogram, cardiac MRI, nuclear scintigraphy, tissue biopsy) performed as part of routine care. The registry record does not specify a required visit schedule or whether the study will perform new biopsies or imaging.

How the study is structured. A prospective observational registry: no experimental treatment is assigned. Participants are followed over time and clinical data, imaging results, treatments, and outcomes are collected (primary outcomes measured over a 3-year timeframe).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Thailand. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 30, 2024
Primary completion
Jun 1, 2029 (estimated)
Study completion
Jun 30, 2030 (estimated)
Target enrollment
105 participants (estimated)
Last updated on registry
May 8, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Mahidol University
Principal investigator
Rungroj Krittayaphong, Professor
Mahidol University
Collaborators
  • Pfizer

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (8)

  • Faculty of Medicine at Chulalongkorn UniversityNot Yet Recruiting

    Bangkok · Thailand

    • Sarinya Puwanant, MD
    • Sarinya Puwanant, MD
  • Faculty of Medicine Ramathibodi hospital, Mahidol UniversityNot Yet Recruiting

    Bangkok · Thailand

    • Teerapat Yingchoncharoen, MD
    • Teerapat Yingchoncharoen, MD
  • Faculty of Medicine Siriraj Hospital, Mahidol UniversityNot Yet Recruiting

    Bangkok · Thailand

    • Kanchalaporn Jirataiporn, B.N.S
    • Srisakul Chirakarnjanakorn, MD
    • Adisak Maneesai, MD
    • Porntera Sethalao, MD
  • Phramongkutklao HospitalNot Yet Recruiting

    Bangkok · Thailand

    • Hutsaya Prasitdumrong, MD
    • Hutsaya Prasitdumrong, MD
  • Faculty of Medicine Chiang Mai UniversityNot Yet Recruiting

    Chiang Mai · Thailand

    • Arintaya Phrommintikul, MD
    • Arintaya Phrommintikul, MD
  • Queen Sirikit Heart Center of The NortheastNot Yet Recruiting

    Khon Kaen · Thailand

    • Vichai Senthong, MD
    • Vichai Senthong, MD
  • Faculty of Medicine, Thammasat UniversityNot Yet Recruiting

    Pathum Thani · Thailand

    • Adisai Buakhamsri, MD
    • Adisai Buakhamsri, MD
  • Prince of Songkla UniversityRecruiting

    Songkhla · Thailand

    • Thammarak Songsangjinda, MD
    • Thammarak Songsangjinda, MD
    • Ply Chichareon, MD, PhD

Terms used on this page · explanations by MedicalUpdates.ai

registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
echocardiogram
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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