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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06321523 | Registry Identifier | ClinicalTrials.gov |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTR-CM patients in Korea | transthyretin amyloid cardiomyopathy (ATTR-CM) patients in Korea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafamidis 61 milligrams | Drug | Tafamidis 61mg as provided in real-world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration | 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 Any Heart Block | 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 Left Ventricular Ejection Fraction | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of cardiovascular hospitalizations | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hopital, Yonsei University Health System | Seoul | Seoul-teukbyeolsi [seoul] | 03722 | South Korea | ||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Change from Baseline in Left Ventricular Wall Thickness | 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 |
| Up to 24 months |
| Samsung Medical Center |
| Seoul |
| Seoul-teukbyeolsi [seoul] |
| 06351 |
| South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |