Hypertrophic Cardiomyopathy Clinical Trial
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
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).
Eligibility Criteria
Key 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.
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There is 1 Location for this study
Los Angeles California, , United States
Los Angeles California, , United States
Stanford California, , United States
New Haven Connecticut, , United States
Athens Georgia, , United States
Chicago Illinois, , United States
Iowa City Iowa, , United States
Boston Massachusetts, , United States
Boston Massachusetts, , United States
Boston Massachusetts, , United States
Saint Louis Missouri, , United States
Morristown New Jersey, , United States
New York New York, , United States
New York New York, , United States
Durham North Carolina, , United States
Portland Oregon, , United States
Bethlehem Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
Nashville Tennessee, , United States
Nashville Tennessee, , United States
Houston Texas, , United States
Houston Texas, , United States
Houston Texas, , United States
Seattle Washington, , United States
Marshfield Wisconsin, , United States
Milwaukee Wisconsin, , United States
Melbourne Victoria, , Australia
Paris , , France
Hamburg , , Germany
Jerusalem , , Israel
Petah Tikva , , Israel
Ramat-Gan , , Israel
Tel Aviv , , Israel
San Benedetto del Tronto Ascoli Piceno, , Italy
Bergamo , , Italy
Bologna , , Italy
Florence , , Italy
Milan , , Italy
Naples , , Italy
Parma , , Italy
Rome , , Italy
Amsterdam Noord-Holland, , Netherlands
Rotterdam , , Netherlands
Utrecht , , Netherlands
Cardiff South Glamergon, , United Kingdom
Sheffield Yorkshire, , United Kingdom
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