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

Transthyretin Amyloid Cardiomyopathy Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06321523
• Other study ID #: B3461122
• Status: Active, not recruiting
• Start date: March 19, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Transthyretin Amyloid Cardiomyopathy

Intervention

Drug:
• Tafamidis 61 milligrams
Tafamidis 61mg as provided in real-world practice

Locations

Country	Name	City	State
Korea, Republic of	Pfizer	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline in six-minute walk test		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	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
Primary	Change From Baseline in Troponin I and Troponin T		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	number of participants with Any Heart Block		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	number of participants with Atrioventricular (AV) block		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	Change From Baseline in Left Ventricular Ejection Fraction		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	Change From a Baseline in Diastolic function grades		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	Change from Baseline in Left Ventricular Wall Thickness		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Primary	Change From Baseline in Global Longitudinal Strain scores		baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Secondary	Frequency of cardiovascular hospitalizations		Up to 24 months
Secondary	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

External Links

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