CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM
Trial ID or NCT#
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
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
- - Males and females between 18 and 85 years of age, inclusive, at screening. - Body mass index <35 kg/m2. - Diagnosed with HCM per the following criteria: - Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease and - 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. - NYHA Functional Class II or III at screening. - Hemoglobin ≥10g/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 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. Key
- - 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). - Moderate-severe valvular aortic stenosis. - 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.
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