Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
Trial ID or NCT#
NCT02862600
Status
RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Euan A. Ashley
Cardiologist,
Heart failure cardiologist
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
Contact us to find out if this trial is right for you.
Contact
Austin Bland
6507256911
View on ClinicalTrials.gov