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

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.

Study Overview

• Status: Completed
• Conditions: Transthyretin Amyloid Cardiomyopathy
• Intervention / Treatment: Drug: Tafamidis 61 milligrams

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
      • Severance Hopital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ATTR-CM patients in Korea; transthyretin amyloid cardiomyopathy (ATTR-CM) patients in Korea	Drug: Tafamidis 61 milligrams; Tafamidis 61mg as provided in real-world practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): October 13, 2025
• Study Completion (Actual): October 13, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Proteostasis Deficiencies; Cardiomyopathies; Amyloidosis
• Other Study ID Numbers: B3461122; NCT06321523 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.