TerminatedPhase 2

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

Stopped: Lack of Efficacy

United States35 participantsStarted 2016-08-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline of VO2MAX at 16 Weeks

Timeframe: end of Period 2 (Week 16)

Trial details

NCT IDNCT02862600

SponsorHeart Metabolics Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-28

Results submitted2017-06-25

View on ClinicalTrials.gov More Cardiomyopathy, Hypertrophic trials