Trial Search Results
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
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
Stanford is currently accepting patients for this trial.
Collaborator: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
- Drug: CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg)
- Drug: Placebo to match CK-3773274
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
- Has an end-diastolic LV wall thickness as measured by the echocardiography core
- ≥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
- 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.
Ages Eligible for Study
18 Years - 85 Years
Genders Eligible for Study