Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Eleclazine
  • Drug: Placebo

Phase:

Phase 2/Phase 3

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.

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting