Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
Trial ID or NCT#
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.
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
- - 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
- - 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
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