WithdrawnPhase 3

Efficacy, Safety, and Tolerability of Perhexiline in Subjects With Hypertrophic Cardiomyopathy and Heart Failure

Stopped: Lack of efficacy in a preceding study.

Plain-language summary

A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure

Who can participate

Age range18 Years

SexALL

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

Inclusion criteria

✓. Adult, at least 18 years of age
✓. Able and willing to give written informed consent Cardiomyopathy-related Criteria
✓. Hypertrophic cardiomyopathy (HCM) with moderate-to-severe heart failure as defined as meeting all of the following criteria:
✓. HCM meeting the 2011 ACCF/AHA Criteria for the Diagnosis of Hypertrophic Cardiomyopathy (Gersh et al. 2011)
✓. Left ventricular hypertrophy (LVH) with maximum LV wall thickness \> 15 mm by echocardiography or cardiac magnetic resonance imaging without an alternative explanation
✓. Left ventricular ejection fraction (LVEF) \> 40%
✓. Able to perform exercise testing but unable to exceed 75% of the predicted age-adjusted maximum level(as determined by METs achieved during exercise testing-eligibility is not based on VO2max)
✓. Normal sinus rhythm at Screening and Baseline (atrial fibrillation pattern acceptable for subjects with known chronic atrial fibrillation)

Exclusion criteria

✕. Pregnant women, women who intend to become pregnant, or woman who are not practicing contraception, either pharmacologically or with a barrier method
✕. Lactating women
✕. CYP2D6 Poor Metabolizer (PM) status, based on genotype known prior to Screening, or as predicted by genotype assessed at Screening CYP2D6 Poor Metabolizer (PM) status is defined as having no functional CYP2D6 alleles by genotyping (exclusively having allele combinations of \*3, \*4, \*5, \*6, \*7, \*8, \*12, \*14).
✕. Any subject who regularly takes a medication known to be a strong inhibitor of CYP2D6 (bupropion, fluoxetine, paroxetine, quinidine, or ritonavir)
✕. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the investigator or sponsor, pose an unacceptable risk to subjects and/or interfere with the interpretation of study data, including but not limited to:
✕. History of a known toxic or inflammatory peripheral neuropathy, such as mononeuritis multiplex, acute or chronic inflammatory demyelinating polyneuropathy (AIDP or CIDP), axonal sensorimotor neuropathies, drug-related neuropathy or neuritis, or diabetic neuropathy (history of a compression neuropathy, such as carpal tunnel syndrome, is acceptable)
✕. Poorly controlled diabetes mellitus (e.g., HbA1c \> 8.5%)
✕. Clinically severe chronic obstructive pulmonary disease (i.e. COPD requiring home oxygen or history of IV or oral steroid use)

What they're measuring

Subject Outcome Variable

Timeframe: 6 months after randomization

Trial details

NCT IDNCT02431221

SponsorHeart Metabolics Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Hypertrophic Cardiomyopathy trials