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 Type
OBSERVATIONAL
Enrollment
13
Tafamidis 61mg as provided in real-world practice
Severance Hopital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Pusan National University Hospital
Busan, South Korea
Gangnam Severance Hospital
Seoul, South Korea
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
Change from baseline in six-minute walk test
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
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
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
Change From Baseline in Troponin I and Troponin T
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Any Heart Block
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Atrioventricular (AV) block
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Left Ventricular Ejection Fraction
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From a Baseline in Diastolic function grades
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from Baseline in Left Ventricular Wall Thickness
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Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Global Longitudinal Strain scores
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Frequency of cardiovascular hospitalizations
Time frame: 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.
Time frame: Up to 24 months