Transthyretin Amyloid Cardiomyopathy (ATTR-CM)NCT06338696
Thailand ATTR-CM Registry
An observational study of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), run by Mahidol University at 8 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
- How many people
- 105 participants
- Where
- 8 sitesThailand
- Study dates
- 30 Jul 2024to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients diagnosed with ATTR-CM,Transthyretin cardiomyopathy, who have either symptomatic or asymptomatic.
Who may be able to join
- 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
Who cannot join
- Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)
- Diagnosed with secondary amyloidosis
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Thailand8 sites, 8 recruiting
- Not yet recruiting
Faculty of Medicine at Chulalongkorn University
Bangkok
Sarinya Puwanant, MD
Sarinya Puwanant, MD
- Not yet recruiting
Faculty of Medicine Ramathibodi hospital, Mahidol University
Bangkok
Teerapat Yingchoncharoen, MD
Teerapat Yingchoncharoen, MD
- Not yet recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok
Kanchalaporn Jirataiporn, B.N.S
Srisakul Chirakarnjanakorn, MD
- Not yet recruiting
Phramongkutklao Hospital
Bangkok
Hutsaya Prasitdumrong, MD
Hutsaya Prasitdumrong, MD
- Not yet recruiting
Faculty of Medicine Chiang Mai University
Chiang Mai
Arintaya Phrommintikul, MD
Arintaya Phrommintikul, MD
- Not yet recruiting
Queen Sirikit Heart Center of The Northeast
Khon Kaen
Vichai Senthong, MD
Vichai Senthong, MD
- Not yet recruiting
Faculty of Medicine, Thammasat University
Pathum Thani
Adisai Buakhamsri, MD
Adisai Buakhamsri, MD
- Recruiting
Prince of Songkla University
Songkhla
Thammarak Songsangjinda, MD
Thammarak Songsangjinda, MD
About this study
Official title: 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.
- Being tested
- No intervention
- Keywords
- Transthyretin amyloid cardiomyopathy (ATTR-CM), Heart Failure, Cardiomyopathy
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| ATTR Cardiomyopathy | Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of death
Measured: 3 years
Rate of heart failure hospitalization
Measured: 3 years
Secondary outcomes (1)
Transthyretin (ATTR) amyloidosis medication
Rate of use and rate of adverse effect of Transthyretin (ATTR) amyloidosis medication
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start30 Jul 2024
- Primary completion1 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Rungroj Krittayaphong, Mahidol University
- Investigators
- Rungroj Krittayaphong, MD, FESC, FACC, Principal investigator, Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338696
- Sponsor's protocol ID
- COA-CREC070/2023
- Status last verified
- May 2025
- First submitted
- 14 Mar 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thailand Transthyretin Amyloid Cardiomyopathy Registry
- ClinicalTrials.gov ID
- NCT06338696
- Acronym / sponsor ID
- COA-CREC070/2023
- Keywords
- Transthyretin amyloid cardiomyopathy (ATTR-CM), Heart Failure, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATTR Cardiomyopathy | – | Other: No interventionPatients diagnosed with ATTR-CM (Transthyretin cardiomyopathy) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with ATTR-CM,Transthyretin cardiomyopathy, who have either symptomatic or asymptomatic.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)
- Diagnosed with secondary amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | ATTR Cardiomyopathy |
Primary outcome
Rate of death
Time frame: 3 years
Rate of heart failure hospitalization
Time frame: 3 years
1 secondary outcome
Transthyretin (ATTR) amyloidosis medication
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Related trials for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Not yet recruitingPhase 2
Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Transthyretin Cardiac Amyloidosis
Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
Enrolling by invitationPhase 3
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
RecruitingPhase 3
CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rungroj Krittayaphong, MD, FESC, FACC principal investigator
Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), run by Mahidol University at 8 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kanchalaporn Jirataiporn, B.N.S. (0635153519, kanchalaporn.jir@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of death (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.