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

NCT06321523 | Completed

• 2 other identifiers: B3461122NCT06321523
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 4

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.

Conditions

Transthyretin Amyloid Cardiomyopathy

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• Change From Baseline in Global Longitudinal Strain scores

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

Secondary Outcomes (2)

• Frequency of cardiovascular hospitalizations

  Up to 24 months

• Frequency of death due to any cause

  Up to 24 months

Study Arms (1)

ATTR-CM patients in Korea

transthyretin amyloid cardiomyopathy (ATTR-CM) patients in Korea

Drug: Tafamidis 61 milligrams

Interventions

Tafamidis 61 milligrams DRUG

Tafamidis 61mg as provided in real-world practice

ATTR-CM patients in Korea

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (more than 19 aged) who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have takne Tafamidis 61mg at least once. Participants will be enrolled through medical chart review from tertiary medical centers in Korea.

You may qualify if:

• 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.

You may not qualify if:

• Presence of other amyloidosis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Severance Hopital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: March 19, 2024
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)