Thailand ATTR-CM Registry | NCT06338696

Studies
Thailand ATTR-CM Registry

NCT06338696

Sponsor

Mahidol University

Status

Recruiting

Last Update Posted

May 8, 2025Actual

Enrollment

105Estimated

Phase

Not provided

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Interventions

No intervention

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2024Actual

Primary Completion Date

Jun 1, 2029Estimated

Completion Date

Jun 30, 2030Estimated

First Submitted Date

Mar 14, 2024

First Submission Date that Met QC Criteria

Mar 28, 2024

First Posted Date

Apr 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2025

Last Update Posted Date

May 8, 2025Actual

Name	Class
Pfizer	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

105Estimated

Label	Type	Description	Intervention Names
ATTR Cardiomyopathy		Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy)	Other: No intervention

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	ATTR Cardiomyopathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of death		3 years
Rate of heart failure hospitalization		3 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kanchalaporn Jirataiporn, B.N.S.	Contact	0635153519		kanchalaporn.jir@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Rungroj Krittayaphong, MD, FESC, FACC	Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine at Chulalongkorn University	Not yet recruiting	Bangkok			Thailand

ID	Term
D006333	Heart Failure
D009202	Cardiomyopathies

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases