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RecruitingNCT06338696Updated May 8, 2025

Thailand ATTR-CM Registry

An observational study in Transthyretin Amyloid Cardiomyopathy (ATTR-CM), sponsored by Mahidol University. Recruiting at 8 sites in Thailand. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Mahidol University · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
105
Ages
18 Years to 100 Years
Sex
All
01

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.

02

Conditions studied

  • Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Keywords

  • Transthyretin amyloid cardiomyopathy (ATTR-CM)
  • Heart Failure
  • Cardiomyopathy
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 105 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)
  • Diagnosed with secondary amyloidosis
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
105 participants (estimated)
Patient registry
No

Groups and cohorts

  • ATTR Cardiomyopathy

    Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy)

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

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

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

    Time frame: 3 years

07

Study locations

1 of 8 sites recruiting
  • Faculty of Medicine at Chulalongkorn University
    Bangkok, Thailand
    • Sarinya Puwanant, MD · Contact
    • Sarinya Puwanant, MD · Principal investigator
    Not yet recruiting
  • Faculty of Medicine Ramathibodi hospital, Mahidol University
    Bangkok, Thailand
    • Teerapat Yingchoncharoen, MD · Contact
    • Teerapat Yingchoncharoen, MD · Principal investigator
    Not yet recruiting
  • Faculty of Medicine Siriraj Hospital, Mahidol University
    Bangkok, Thailand
    • Kanchalaporn Jirataiporn, B.N.S · Contact
    • Srisakul Chirakarnjanakorn, MD · Principal investigator
    • Adisak Maneesai, MD · Sub investigator
    • Porntera Sethalao, MD · Sub investigator
    Not yet recruiting
  • Phramongkutklao Hospital
    Bangkok, Thailand
    • Hutsaya Prasitdumrong, MD · Contact
    • Hutsaya Prasitdumrong, MD · Principal investigator
    Not yet recruiting
  • Faculty of Medicine Chiang Mai University
    Chiang Mai, Thailand
    • Arintaya Phrommintikul, MD · Contact
    • Arintaya Phrommintikul, MD · Principal investigator
    Not yet recruiting
  • Queen Sirikit Heart Center of The Northeast
    Khon Kaen, Thailand
    • Vichai Senthong, MD · Contact
    • Vichai Senthong, MD · Principal investigator
    Not yet recruiting
  • Faculty of Medicine, Thammasat University
    Pathum Thani, Thailand
    • Adisai Buakhamsri, MD · Contact
    • Adisai Buakhamsri, MD · Principal investigator
    Not yet recruiting
  • Prince of Songkla University
    Songkhla, Thailand
    • Thammarak Songsangjinda, MD · Contact
    • Thammarak Songsangjinda, MD · Principal investigator
    • Ply Chichareon, MD, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06338696
Lead sponsor
Mahidol University
Collaborators
Pfizer
Responsible party
Rungroj Krittayaphong (Professor, Mahidol University) — Principal investigator
First posted
Apr 1, 2024
Start date
Jul 30, 2024
Primary completion
Jun 1, 2029 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
May 8, 2025

Study contacts

Kanchalaporn Jirataiporn, B.N.S.
Contact
kanchalaporn.jir@mahidol.ac.th
0635153519
Rungroj Krittayaphong, MD, FESC, FACC
principal investigator · Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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