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

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytokinetics
• Collaborator: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Criteria

Key Inclusion Criteria:

• 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 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).

• 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.