A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
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Phase
—
Status
Completed
Study type
Observational
Enrollment
13actual
Sites
4
Country
South Korea
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-19 | actual | When the study began enrolling |
| Primary completion | 2025-10-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-13 | actual | The whole study's end, after follow-up |
| First posted | 2024-03-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Transthyretin Amyloid Cardiomyopathy
Intervention
- Drug: Tafamidis 61 milligrams
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Change From Baseline in New York Heart Association (NYHA) Classification
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from baseline in six-minute walk test
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
measured 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
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Troponin I and Troponin T
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Any Heart Block
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Atrioventricular (AV) block
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Left Ventricular Ejection Fraction
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From a Baseline in Diastolic function grades
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from Baseline in Left Ventricular Wall Thickness
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Global Longitudinal Strain scores
measured baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
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