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

• Status: Terminated
• Trial end date: 2017-05-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heart Metabolics Limited
• Treatments: Perhexiline

Criteria

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