ATTR-Cardiomyopathy Stabilization Following Tafamidis Therapy

Status unconfirmed

Conditions studied: Transthyretin Amyloidosis

In brief

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: 1. Utilize cardiac magnetic resonance to assess stabilization of ATTR after Tafamidis therapy based on extracellular volume mapping. 2. Investigate left ventricular myocardial mass, native T1, T2, and extracellular volume mapping after 12 month follow-up. 3. Utilize cardiac magnetic resonance feature tracking at baseline and at 12 month follow-up.

Key facts

Study ID

NCT04513600

Run by

The Christ Hospital

People needed

131

Starts

2020-08-01

Expected to finish

2023-08-01

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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