Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Orthopedic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/18/2017 |
| Start Date: | August 2016 |
| End Date: | August 2017 |
| Contact: | Heart Metabolics Call Center |
| Email: | info@heartmetabolics.com |
| Phone: | 1-800-206-2434 |
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
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.
(efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe
heart failure following dosing for 16 weeks.
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
We found this trial at
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