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

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Trial ID: NCT05186818

Purpose

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

Official Title

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

Stanford Investigator(s)

Matthew Wheeler
Matthew Wheeler

Associate Professor of Medicine (Cardiovascular Medicine)

Masataka Kawana

Assistant Professor of Medicine (Cardiovascular Medicine)

Eligibility


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 ≤90% 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 is only excluded IF:

      - rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation
      ablation procedure, or antiarrhythmic therapy) has been required ≤6 months prior
      to screening.

      - rate control and anticoagulation have not been achieved for at least 6 months
      prior to screening.

   - History of syncope or sustained ventricular tachyarrhythmia with exercise within 6
   months prior to screening.

   - Has received prior treatment with CK-3773274 or mavacamten.

Intervention(s):

drug: CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg)

drug: Placebo to match CK-3773274

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Marino
650-725-6911