CompletedNot Applicable

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

South Korea13 participantsStarted 2024-03-19

Plain-language 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.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Change from baseline in six-minute walk test

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)

Timeframe: 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

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Change From Baseline in Troponin I and Troponin T

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

number of participants with Any Heart Block

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

number of participants with Atrioventricular (AV) block

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Trial details

NCT IDNCT06321523

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10-13

View on ClinicalTrials.gov More Transthyretin Amyloid Cardiomyopathy trials

Plain-language summary

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Change from baseline in six-minute walk test

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)

Timeframe: 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

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

Change From Baseline in Troponin I and Troponin T

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

number of participants with Any Heart Block

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg

number of participants with Atrioventricular (AV) block

Timeframe: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg