Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

This study is being performed to understand the effect of different doses of CK-3773274 on patients with obstructive hypertrophic cardiomyopathy (oHCM).

Official Title

A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Keywords

Obstructive Hypertrophic Cardiomyopathy CK-3773274 CK-274 oHCM REDWOOD-HCM Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy

Eligibility

You can join if…

Open to people ages 18-85

  • Males and females between 18 and 85 years of age at screening.
  • Body weight is ≥45 kg at screening.
  • Diagnosed with oHCM per the following criteria:
  • Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
  • Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
  • Adequate acoustic windows for echocardiography.
  • Has LVOT-G during screening as follows:
  • Resting gradient ≥50 mmHg OR
  • Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
  • LVEF ≥60% at screening.
  • New York Heart Association (NYHA) Class II or III at screening.
  • Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for >4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study.
  • For Cohort 3: Patients must be taking disopyramide. Patients should have been on stable disopyramide doses for >4 weeks prior to screening and anticipate remaining on the same medication regimen during the study.

You CAN'T join if...

  • Aortic stenosis or fixed subaortic obstruction.
  • Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
  • History of LV systolic dysfunction (LVEF <45%) at any time during their clinical course.
  • Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
  • Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period.
  • For Cohorts 1 and 2: Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening. (For Cohort 3, use of disopyramide is required).
  • Paroxysmal atrial fibrillation or flutter documented during the screening period.
  • Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months).
  • History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
  • Has received prior treatment with CK-3773274 or is currently receiving mavacamten.

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • Cedar-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cytokinetics
ID
NCT04219826
Phase
Phase 2
Study Type
Interventional
Last Updated