Clinical trial NCT02291237: Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hypertrophic Cardiomyopathy
Keywords: hypertrophic cardiomyopathy
hcm
hocm
hypertrophic myocardiopathy
hypertrophic obstructive cardiomyopathies
cardiomyopathy
hypertrophic
familial hypertrophic cardiomyopathy
genetic heart disease
echocardiography
cardiopulmonary exercise testing
exercise Capacity
heart failure
angina
dyspnea
diastolic dysfunction
microvascular ischemia
late sodium current inhibitor
GS-6615
late INA
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in Treadmill Exercise Time From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in Treadmill Exercise Time From Baseline to Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Heart Institute
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Athens
country: United States
facility: Athens Regional Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Brigham & Women's Hospital and Harvard Medical School
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/ New York Presbyterian
state: New York
city: New York
country: United States
facility: NYU School of Medicine Pediatrics
state: New York
city: Durham
country: United States
facility: Duke Health Center at Southpoint
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic Research Institute
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Jerusalem
country: Israel
facility: Ein Kerem-Hadassah Medical Organization
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: San Benedetto del Tronto
country: Italy
facility: Madonna del Soccorso Hospital
state: Ascoli Piceno
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milan
country: Italy
facility: Ospedale San Raffaele S.r.l.
city: Naples
country: Italy
facility: Azienda Ospedaliera Monaldi
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Amsterdam
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: South Glamergon
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
state: Yorkshire
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.