Status:
TERMINATED
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
Lead Sponsor:
Gilead Sciences
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 (CP...
Eligibility Criteria
Inclusion
- Key
- 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)
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
February 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2017
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT02291237
Start Date
February 5 2015
End Date
February 17 2017
Last Update
September 24 2018
Active Locations (46)
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1
Cedars-Sinai Heart Institute
Los Angeles, California, United States
2
University of California Los Angeles
Los Angeles, California, United States
3
Stanford University
Stanford, California, United States
4
Yale New Haven Hospital
New Haven, Connecticut, United States