Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
Trial ID or NCT#
The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).
Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
- - Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis
- - Exertional symptoms including at least one of the following:
- - New York Heart Association (NYHA) Class ≥ II dyspnea
- - Canadian Cardiovascular Society (CCS) Class ≥ II angina
- - Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight
- - Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)
- - Known aortic valve stenosis (moderate or severe)
- - Known coronary artery disease
- - Left ventricular systolic dysfunction (ejection fraction < 50%)
- - Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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