Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
- Registration Number
- NCT02291237
- Lead Sponsor
- Gilead Sciences
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 172
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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.
Trial Locations
- Locations (46)
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
Academisch Medisch Centrum Amsterdam
🇳🇱Amsterdam, Noord-Holland, Netherlands
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Florence, Italy
Ospedale San Raffaele S.r.l.
🇮🇹Milan, Italy
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
Brigham & Women's Hospital and Harvard Medical School
🇺🇸Boston, Massachusetts, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, 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
Duke Health Center at Southpoint
🇺🇸Durham, North Carolina, United States
NYU School of Medicine Pediatrics
🇺🇸New York, New York, 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
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Southwestern Medical Center
🇺🇸Houston, Texas, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Marshfield Clinic Research Institute
🇺🇸Marshfield, Wisconsin, United States
Erasmus MC
🇳🇱Rotterdam, Netherlands
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Ein Kerem-Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Azienda Ospedaliero Universitaria Di Bologna
🇮🇹Bologna, Italy
Azienda Ospedaliera Monaldi
🇮🇹Naples, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
University Hospital of Wales
🇬🇧Cardiff, South Glamergon, United Kingdom
Northern General Hospital
🇬🇧Sheffield, Yorkshire, United Kingdom
Sheba Medical Center
🇮🇱Ramat-Gan, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Washington
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Madonna del Soccorso Hospital
🇮🇹San Benedetto del Tronto, Ascoli Piceno, Italy
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands