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Completed

NCT Number: NCT06321523

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

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.

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Key information

Conditions

Transthyretin Amyloid Cardiomyopathy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Seoul, Seoul-teukbyeolsi [seoul], South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tafamidis 61 milligrams

Drug

Tafamidis 61mg as provided in real-world practice

Primary outcomes

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

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

  2. Change from baseline in six-minute walk test

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

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

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

  4. Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration

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

  5. Change From Baseline in Troponin I and Troponin T

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

  6. number of participants with Any Heart Block

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

  7. number of participants with Atrioventricular (AV) block

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

  8. Change From Baseline in Left Ventricular Ejection Fraction

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

  9. Change From a Baseline in Diastolic function grades

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

  10. Change from Baseline in Left Ventricular Wall Thickness

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

  11. Change From Baseline in Global Longitudinal Strain scores

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

Secondary outcomes

  1. Frequency of cardiovascular hospitalizations

    Time frame: Up to 24 months

  2. Frequency of death due to any cause

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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