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Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
Recruiting
I'm InterestedTrial ID: NCT02862600
Purpose
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.
Official Title
A Phase 2, Multi-Center, Open-Label, Ascending Dose Study on the Efficacy, Safety and Tolerability of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure With Preserved Left Ventricular Function
Stanford Investigator(s)
Euan A. Ashley
Associate Dean, School of Medicine, Roger and Joelle Burnell Professor of Genomics and Precision Health, Professor of Medicine (Cardiovascular Medicine), of Genetics, of Biomedical Data Science and, by courtesy, of Pathology
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
Intervention(s):
drug: Perhexiline
drug: Perhexiline
device: Use of bioanalytical assay to monitor plasma levels of perhexiline
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Austin Bland
6507256911