Thailand ATTR-CM Registry

NCT06338696 | Recruiting

• 1 other identifier: COA-CREC070/2023
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Keywords

Transthyretin amyloid cardiomyopathy (ATTR-CM); Heart Failure; Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Rate of death

  3 years

• Rate of heart failure hospitalization

  3 years

Secondary Outcomes (1)

• Transthyretin (ATTR) amyloidosis medication

  3 years

Study Arms (1)

ATTR Cardiomyopathy

Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy)

Other: No intervention

Interventions

No intervention OTHER

No intervention

ATTR Cardiomyopathy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead
• Pfizer: collaborator

Study Sites (8)

Faculty of Medicine at Chulalongkorn University

Bangkok, Thailand

NOT YET RECRUITING

Faculty of Medicine Ramathibodi hospital, Mahidol University

Bangkok, Thailand

NOT YET RECRUITING

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand

NOT YET RECRUITING

Phramongkutklao Hospital

Bangkok, Thailand

NOT YET RECRUITING

Faculty of Medicine Chiang Mai University

Chiang Mai, Thailand

NOT YET RECRUITING

Queen Sirikit Heart Center of The Northeast

Khon Kaen, Thailand

NOT YET RECRUITING

Faculty of Medicine, Thammasat University

Pathum Thani, Thailand

NOT YET RECRUITING

Prince of Songkla University

Songkhla, Thailand

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rungroj Krittayaphong, MD, FESC, FACC

  Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kanchalaporn Jirataiporn, B.N.S.

CONTACT

0635153519; kanchalaporn.jir@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 1, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

TH (8)