Clinical trial NCT06321523: A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transthyretin Amyloid Cardiomyopathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change from baseline in six-minute walk test
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change From Baseline in Troponin I and Troponin T
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: number of participants with Any Heart Block
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: number of participants with Atrioventricular (AV) block
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change From Baseline in Left Ventricular Ejection Fraction
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change From a Baseline in Diastolic function grades
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change from Baseline in Left Ventricular Wall Thickness
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
measure: Change From Baseline in Global Longitudinal Strain scores
timeFrame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Secondary outcomes:
measure: Frequency of cardiovascular hospitalizations
timeFrame: Up to 24 months
measure: Frequency of death due to any cause
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: