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

Hypertrophic Cardiomyopathy Clinical Trial

— LIBERTY-HCM  

Official title:

Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02291237
• Other study ID #: GS-US-361-1157
• Secondary ID: 2013-004429-97
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: February 5, 2015
• Est. completion date: February 17, 2017

Study information

• Verified date: February 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 172
• Est. completion date: February 17, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Drug:
• Eleclazine
Tablet (s) administered orally once daily
• Placebo
Placebo to match eleclazine administered orally once daily

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
France	Hôpital Européen Georges Pompidou	Paris
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg
Israel	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
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	Madonna del Soccorso Hospital	San Benedetto del Tronto	Ascoli Piceno
Netherlands	Academisch Medisch Centrum Amsterdam	Amsterdam	Noord-Holland
Netherlands	Erasmus MC	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht
United Kingdom	University Hospital of Wales	Cardiff	South Glamergon
United Kingdom	Northern General Hospital	Sheffield	Yorkshire
United States	Athens Regional Medical Center	Athens	Georgia
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
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	Northwestern Memorial Hospital	Chicago	Illinois
United States	Duke Health Center at Southpoint	Durham	North Carolina
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 Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Cedars-Sinai Heart Institute	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	Marshfield Clinic Research Institute	Marshfield	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Morristown Medical Center	Morristown	New Jersey
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
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	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Israel,  Italy,  Netherlands,  United Kingdom, 

References & Publications (1)

Olivotto I, Hellawell JL, Farzaneh-Far R, Blair C, Coppini R, Myers J, Belardinelli L, Maron MS. Novel Approach Targeting the Complex Pathophysiology of Hypertrophic Cardiomyopathy: The Impact of Late Sodium Current Inhibition on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM) Trial. Circ Heart Fail. 2016 Mar;9(3):e002764. doi: 10.1161/CIRCHEARTFAILURE.115.002764. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24		Baseline to Week 24
Secondary	Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12		Baseline to Week 12
Secondary	Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From 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.	Baseline to Week 24
Secondary	Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From 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.	Baseline to Week 12
Secondary	Change in Treadmill Exercise Time From Baseline to Week 24	Treadmill exercise time is the time to peak exercise.	Baseline to Week 24
Secondary	Change in Treadmill Exercise Time From Baseline to Week 12	Treadmill exercise time is the time to peak exercise.	Baseline to Week 12