Recruiting

Tafamidis

Sponsor:

The Christ Hospital

Code:

NCT04513600

Conditions

Transthyretin Amyloidosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cardiac MRI

Study Details

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:

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.

Conditions

Transthyretin Amyloidosis

Study ID

NCT04513600

Start date

Aug 1, 2020

Status verified date

Jan, 2021

Completion date

Aug 1, 2023

Anticipated

Primary completion date

Aug 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

131 participants

Anticipated

Interventions and Outcome Measures

Interventions

Cardiac MRI

Lab work: Hs- Troponin, Serum N-terminal-proBNP CMR: Native T1, Native T2, extracellular volume, strain and strain rate.

Primary outcome measure

  • Stabilization of Transthyretin Amyloid Cardiomyopathy [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Wojciech Mazur, MD

513-206-1120wojciech.mazur@thechristhospital.com

Cassady Palmer, BS

513-585-1400cassady.palmer@thechristhospital.com

Locations

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Wojciech Mazur, MD

513-206-1120wojciech.mazur@thechristhospital.com

Cassady Palmer, BS

513-585-1400cassady.palmer@thechristhospital.com

More Information

Sponsor

The Christ Hospital

Last update posted

Jan 27, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Christ Hospital on 2021-01-27.