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Clinical Trials/EUCTR2021-003536-92-HU
EUCTR2021-003536-92-HUActive, not recruitingPhase 1

A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Cytokinetics, Inc.0 sites270 target enrollmentStarted: February 23, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
270
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Males and females between 18 and 85 years of age, inclusive, at screening.
  • •- Body mass index <35 kg/m^2.
  • •- Diagnosed with HCM per the following criteria:
  • •a. Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease and
  • •b. Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory of:
  • •=15 mm in one or more myocardial segments OR
  • •=13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM
  • •- Has resting LVOT-G =30 mmHg and post-Valsalva LVOT-G =50 mmHg during screening as determined by the echocardiography core laboratory
  • •- LVEF =60% at screening as determined by the echocardiography core laboratory.
  • •- New York Heart Association (NYHA) Functional Class II or III at screening
  • •- Hemoglobin =10 g/dL at screening.
  • •- Respiratory exchange ratio (RER) =1.05 and pVO2 <80% predicted on the screening CPET per the core laboratory.
  • •- Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on a stable doses for >6 weeks prior to randomization and anticipate remaining on the same medication regimen during the trial. Patients treated with disopyramide must also be concomitantly treated with a beta blocker and/or calcium channel blocker.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 189
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 81

Exclusion Criteria

  • •- Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
  • •- Significant valvular heart disease (per investigator judgment).
  • •a) Moderate-severe valvular aortic stenosis.
  • •b) Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve.
  • •- History of LV systolic dysfunction (LVEF <45%) or stress cardiomyopathy at any time during their clinical course.
  • •- Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations).
  • •- Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the trial period.
  • •- Documented paroxysmal atrial fibrillation during the screening period.
  • •- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation 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 mavacamten.
  • •Exclusion Criteria for CMR Sub-study
  • •- Inability to tolerate CMR.
  • •- Has an implantable cardioverter-defibrillator (ICD).
  • •- Has a cardiac pacemaker.

Investigators

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