Thailand ATTR-CM Registry

May 5, 2025 updated by: Rungroj Krittayaphong, Mahidol University

Thailand Transthyretin Amyloid Cardiomyopathy 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Not yet recruiting
        • Phramongkutklao Hospital
        • Contact:
          • Hutsaya Prasitdumrong, MD
        • Principal Investigator:
          • Hutsaya Prasitdumrong, MD
      • Bangkok, Thailand
        • Not yet recruiting
        • Faculty of Medicine at Chulalongkorn University
        • Contact:
          • Sarinya Puwanant, MD
        • Principal Investigator:
          • Sarinya Puwanant, MD
      • Bangkok, Thailand
        • Not yet recruiting
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University
        • Contact:
          • Teerapat Yingchoncharoen, MD
        • Principal Investigator:
          • Teerapat Yingchoncharoen, MD
      • Bangkok, Thailand
        • Not yet recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
          • Kanchalaporn Jirataiporn, B.N.S
        • Principal Investigator:
          • Srisakul Chirakarnjanakorn, MD
        • Sub-Investigator:
          • Adisak Maneesai, MD
        • Sub-Investigator:
          • Porntera Sethalao, MD
      • Chiang Mai, Thailand
        • Not yet recruiting
        • Faculty of Medicine Chiang Mai University
        • Contact:
          • Arintaya Phrommintikul, MD
        • Principal Investigator:
          • Arintaya Phrommintikul, MD
      • Khon Kaen, Thailand
        • Not yet recruiting
        • Queen Sirikit Heart Center of The Northeast
        • Contact:
          • Vichai Senthong, MD
        • Principal Investigator:
          • Vichai Senthong, MD
      • Pathum Thani, Thailand
        • Not yet recruiting
        • Faculty of Medicine, Thammasat University
        • Contact:
          • Adisai Buakhamsri, MD
        • Principal Investigator:
          • Adisai Buakhamsri, MD
      • Songkhla, Thailand
        • Recruiting
        • Prince of Songkla University
        • Contact:
          • Thammarak Songsangjinda, MD
        • Principal Investigator:
          • Thammarak Songsangjinda, MD
        • Sub-Investigator:
          • Ply Chichareon, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with ATTR-CM,Transthyretin cardiomyopathy, who have either symptomatic or asymptomatic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ATTR Cardiomyopathy
Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy)
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of death
Time Frame: 3 years
3 years
Rate of heart failure hospitalization
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transthyretin (ATTR) amyloidosis medication
Time Frame: 3 years
Rate of use and rate of adverse effect of Transthyretin (ATTR) amyloidosis medication
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Rungroj Krittayaphong, MD, FESC, FACC, Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA-CREC070/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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