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

Phase 3TerminatedNCT02291237

Gilead Sciences172 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

172

Conditions

Hypertrophic Cardiomyopathy

Interventions

EleclazineDRUG

Tablet (s) administered orally once daily

PlaceboDRUG

Placebo to match eleclazine administered orally once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (46)

Outcomes

Primary Outcomes

Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24

Time frame: Baseline to Week 24

Secondary Outcomes

Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12

Time frame: Baseline to Week 12

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.

Time frame: Baseline to Week 24

Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12

Time frame: Baseline to Week 12

Change in Treadmill Exercise Time From Baseline to Week 24

Treadmill exercise time is the time to peak exercise.

Time frame: Baseline to Week 24

Change in Treadmill Exercise Time From Baseline to Week 12

Treadmill exercise time is the time to peak exercise.

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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Cedars-Sinai Heart Institute

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

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