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Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
Trial ID or NCT#
Status
NOT 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
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
CONTACT
Austin Bland
(650) 725-6911
View on ClinicalTrials.gov
About this Clinical Trial
Your Message Will Go To
Austin Bland6507256911