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

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:
    • 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.

Exclusion Criteria:

  • Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (e.g., 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 (e.g., 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 (e.g., 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.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Melissa Lyle, M.D.

Closed for enrollment

Contact information:

Indira Becerrit Rojas

becerrit.indira@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Geske, M.D.

Closed for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available