Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

Phase 2

Terminated

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 (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.
Eleclazine	Eleclazine	Eleclazine 30 mg single loading dose followed by 3 mg daily maintenance dose up until Week 12, then 6 mg daily maintenance dose from Week 12 at least Week 24, followed by eleclazine 6 mg in an open-label extension period.
Placebo	Eleclazine	Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.

Primary Outcome Measures

Name	Time	Method
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24	Baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12	Baseline to Week 12	The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12	Baseline to Week 12
Change in Treadmill Exercise Time From Baseline to Week 12	Baseline to Week 12	Treadmill exercise time is the time to peak exercise.
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24	Baseline to Week 24	The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Change in Treadmill Exercise Time From Baseline to Week 24	Baseline to Week 24	Treadmill exercise time is the time to peak exercise.

Locations (46): Cedars-Sinai Heart Institute
🇺🇸
Los Angeles, California, United States
University of California Los Angeles
🇺🇸
Los Angeles, California, United States
Stanford University
🇺🇸
Stanford, California, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Athens Regional Medical Center
🇺🇸
Athens, Georgia, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Brigham & Women's Hospital and Harvard Medical School
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
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Cedars-Sinai Heart Institute
🇺🇸Los Angeles, California, United States