Clinical Trial: A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Official Title: MEMENTO - A Phase 3b/4, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact
Brief Summary: The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York Heart Association (NYHA) Functional Class II or III].
Detailed Summary:
Sponsor: Bristol-Myers Squibb
Current Primary Outcome:
Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment:
- A decrease of at least 5 mL/m2 in LAVI from baseline
- A decrease of at least 5 g/m2 in LVMI from baseline
Original Primary Outcome:
Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment:
- A decrease of at least 5 mL/m2 in LAVI from baseline
- A decrease of at least 5 g/m2 in LVMI from baseline
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bristol-Myers Squibb
Dates:
Date Received: October 27, 2023
Date Started: December 30, 2023
Date Completion: December 30, 2023
Last Updated: December 15, 2023
Last Verified: December 01, 2023
