A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE MAVACAMTEN IN ADULTS WITH SYMPTOMATIC OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY WHO ARE ELIGIBLE FOR SEPTAL REDUCTION THERAPY
Brief description of study
The purpose of this study is to evaluate the effect of mavacamten versus a placebo on reducing the number of septal reduction therapy (SRT) procedures performed in patients with symptomatic, obstructive hypertrophic cardiomyopathy (oHCM, also known as HOCM). SRT procedures include septal myectomy, a surgical, open heart procedure, and ethanol ablation (also known as alcohol septal ablation) which is a type of cardiac catheterization. These procedures are performed to reduce the thickness of the septal wall of your heart (The wall between the right and left side of the heart). Mavacamten is being tested to determine whether it helps the heart pump better and may reduce the need for SRT by reducing the obstruction. Mavacamten is an investigational drug, referred to as “study drug” in this consent form. This means that it has not been approved by the Food and Drug Administration (FDA) or any regulatory agency for routine clinical use, including the treatment of HCM.
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