IRB Study Number 22-1122
Status Recruiting
Phase Phase 3
Institute Heart and Vascular Institute
Description
The purpose of this study is to evaluate the effect of an investigational medication, mavacamten, versus a placebo, to find out if treatment with mavacamten for 52 weeks reduces shortness of breath and fatigue and increases exercise capacity in patients with nHCM, non-obstructive hypertrophic cardiomyopathy (nHCM).
On April 28, 2022, Mavacamten was approved in the United States by the Food and Drug Administration (FDA) for use in adult patients with symptomatic obstructive hypertrophic cardiomyopathy, however it has not been approved for use in patients with symptomatic non-obstructive hypertrophic cardiomyopathy.
Enrolled patients will take study medication once a day while in the study, and return to the Cleveland Clinic approximately 30 times for study related visits over the following 2.5 years.
Inclusion Criteria
1) Diagnosis of HCM
2) New York Heart Association (NYHA) Class II or III
3) Women must have documented proof that they are not of childbearing potential or must use a highly effective contraceptive method
Exclusion Criteria
1) Women who are breastfeeding or pregnant
2) Heart transplant recipient or listed for heart transplant
3) Gastrointestinal surgery or gastrointestinal disorder that could interfere with absorption of study treatment
