Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at San Francisco, California and other locations
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.

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.
  • Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening.
  • 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