Trial Search Results

Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure

The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Heart Metabolics Limited

Stanford Investigator(s):

Intervention(s):

  • Drug: Perhexiline
  • Device: Use of bioanalytical assay to monitor plasma levels of perhexiline

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - Hypertrophic cardiomyopathy with symptoms of moderate-to-severe heart failure

   - Left ventricular hypertrophy with maximum LV wall thickness ≥ 15 mm

   - Left ventricular ejection fraction ≥ 50%

   - Able to perform exercise testing but unable to exceed 75% of the predicted
   age-adjusted maximum level

Key Exclusion Criteria:

   - CYP2D6 Poor Metabolizer (PM) status

   - History of a known chronic liver disease

   - ALT, AST, alkaline phosphatase, or LDH > 1.5 x upper limit of normal

   - Total Bilirubin > 2.0 x upper limit of normal

   - Severe LV outflow obstruction

   - Asymptomatic patients or cardiomyopathy-related criteria as per protocol

   - QT interval related criteria as per protocol

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Austin Bland
6507256911
Recruiting