A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Clinical Benefit of Tafamidis 61mg for Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Patients in Korean Population in the Real-world Setting, Multicenter, Non-interventional Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06321523

Enrollment

Registered

2024-03-20

Start date

2024-03-19

Completion date

2025-10-13

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin Amyloid Cardiomyopathy

Brief summary

The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM). This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.

Interventions

DRUGTafamidis 61 milligrams

Tafamidis 61mg as provided in real-world practice

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥19 years * Patients diagnosed with ATTR-CM (ATTRwt and ATTRv) with tissue biopsy or nuclear scintigraphy * Patients who was prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.

Exclusion criteria

* Presence of other amyloidosis

Design outcomes

Primary

Measure	Time frame
Change From Baseline in Global Longitudinal Strain scores	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From a Baseline in Diastolic function grades	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from Baseline in Left Ventricular Wall Thickness	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from baseline in six-minute walk test	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Troponin I and Troponin T	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Any Heart Block	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Atrioventricular (AV) block	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Left Ventricular Ejection Fraction	baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Secondary

Measure	Time frame	Description
Frequency of death due to any cause	Up to 24 months	This includes participants who discontinue for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device.
Frequency of cardiovascular hospitalizations	Up to 24 months	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026