A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Active, not recruiting
- Conditions
- Transthyretin Amyloid Cardiomyopathy
- Interventions
- Registration Number
- NCT06321523
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ATTR-CM patients in Korea Tafamidis 61 milligrams transthyretin amyloid cardiomyopathy (ATTR-CM) patients in Korea
- Primary Outcome Measures
Name Time Method 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 number of participants with Any Heart Block 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 Atrioventricular (AV) block 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 a Baseline in Diastolic function grades baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg 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 Left Ventricular Wall Thickness 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 Baseline in Global Longitudinal Strain scores baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
- Secondary Outcome Measures
Name Time Method Frequency of cardiovascular hospitalizations Up to 24 months Frequency of death due to any cause 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.
Trial Locations
- Locations (1)
Pfizer
🇰🇷Seoul, Korea, Republic of