Status:
UNKNOWN
ATTR-Cardiomyopathy Stabilization Following Tafamidis Therapy
Lead Sponsor:
The Christ Hospital
Collaborating Sponsors:
The Cleveland Clinic
Ohio State University
Conditions:
Transthyretin Amyloidosis
Eligibility:
All Genders
18-90 years
Brief Summary
The study will investigate the stabilization effects of Tafamidis utilizing cardiac imaging cardiac magnetic resonance imaging (CMR). The investigators propose to pursue the following specific aims: ...
Detailed Description
The investigators hypothesize that participants with earlier stages (NYHA Class I and Class II) of ATTR wild type and ATTR mutant will demonstrate stabilization of ATTR following 1 year of Tafamidis. ...
Eligibility Criteria
Inclusion
- Patients will be included if they meet the following criteria:
- 18 and 90 years of age
- Transthyretin amyloid cardiomyopathy (ATTRwt or ATTRm) confirmed by genetic testing and/or presence of transthyretin precursor protein confirmed on immunohistochemical analysis, and/or scintigraphy
- History of heart failure (NYHA I, II, or III)
- Agreeable to treatment with Tafamidis
Exclusion
- Patients will be excluded if any one of the following criteria are not met:
- Heart failure not due to transthyretin amyloid cardiomyopathy
- New York Heart Association (NYHA) class IV heart failure
- Presence of light-chain amyloidosis (serum or urine)
- Implanted cardiac device at baseline
- Treatment with ATTR stabilizer or gene silencer within the past 6 months
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT04513600
Start Date
August 1 2020
End Date
August 1 2023
Last Update
January 27 2021
Active Locations (1)
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1
The Christ Hospital
Cincinnati, Ohio, United States, 45219