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).

View Eligibility Criteria

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.

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT02291237

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There is 1 Location for this study

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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
Washington University School of Medicine
Saint Louis Missouri, , United States
Morristown Medical Center
Morristown New Jersey, , United States
Columbia University Medical Center/ New York Presbyterian
New York New York, , United States
NYU School of Medicine Pediatrics
New York New York, , United States
Duke Health Center at Southpoint
Durham North Carolina, , United States
Oregon Health and Science University
Portland Oregon, , United States
St. Luke's University Health Network
Bethlehem Pennsylvania, , United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, , United States
St. Thomas Research Institute
Nashville Tennessee, , United States
Vanderbilt University Medical Center
Nashville Tennessee, , United States
Houston Methodist Hospital
Houston Texas, , United States
Texas Heart Institute
Houston Texas, , United States
UT Southwestern Medical Center
Houston Texas, , United States
University of Washington
Seattle Washington, , United States
Marshfield Clinic Research Institute
Marshfield Wisconsin, , United States
Medical College of Wisconsin
Milwaukee Wisconsin, , United States
The Alfred Hospital
Melbourne Victoria, , Australia
Hôpital Européen Georges Pompidou
Paris , , France
Universitätsklinikum Hamburg Eppendorf
Hamburg , , Germany
Ein Kerem-Hadassah Medical Organization
Jerusalem , , Israel
Rabin Medical Center
Petah Tikva , , Israel
Sheba Medical Center
Ramat-Gan , , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , , Israel
Madonna del Soccorso Hospital
San Benedetto del Tronto Ascoli Piceno, , Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo , , Italy
Azienda Ospedaliero Universitaria Di Bologna
Bologna , , Italy
Azienda Ospedaliera Universitaria Careggi
Florence , , Italy
Ospedale San Raffaele S.r.l.
Milan , , Italy
Azienda Ospedaliera Monaldi
Naples , , Italy
Azienda Ospedaliero Universitaria di Parma
Parma , , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome , , Italy
Academisch Medisch Centrum Amsterdam
Amsterdam Noord-Holland, , Netherlands
Erasmus MC
Rotterdam , , Netherlands
University Medical Center Utrecht
Utrecht , , Netherlands
University Hospital of Wales
Cardiff South Glamergon, , United Kingdom
Northern General Hospital
Sheffield Yorkshire, , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT02291237

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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