This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
CK-3773274 tablets administered orally
CK-3773274 tablets administered orally
Placebo administered orally
Cedar-Sinai Medical Center
Los Angeles, California, United States
Incidence of adverse events observed during dosing of CK--3773274 in patients with HCM
Patient incidence of reported adverse events (AEs)
Time frame: 14 weeks
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM
Patient incidence of left ventricular ejection fraction (LVEF) \< 50%
Time frame: 14 weeks
Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM
Patient incidence of reported serious adverse events (SAEs)
Time frame: 14 weeks
Concentration-response relationship of CK-3773274 on the resting left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment in patients with oHCM (Cohorts 1, 2, 3 only)
Slope of the relationship of the plasma concentration of CK-3773274 to the change from baseline in the resting LVOT-G
Time frame: 10 weeks
Concentration-response relationship of CK-3773274 on the post-Valsalva left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment in patients with oHCM (Cohorts 1, 2, 3 only)
Slope of the relationship of the plasma concentration of CK-3773274 to the change from baseline in the post-Valsalva LVOT-G
Time frame: 10 weeks
Dose response relationship on LVOT-G of CK-3773274 in patients with oHCM at rest (Cohorts 1, 2, 3 only)
Change from baseline in resting LVOT-G over time as a function of dose
Time frame: 10 weeks
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UCSF Medical Center
San Francisco, California, United States
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Evanston, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York University Langone Health Medical Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
...and 12 more locations
Dose response relationship on LVOT-G of CK-3773274 in patients with oHCM post-Valsalva (Cohorts 1, 2, 3 only)
Change from baseline in post-Valsalva LVOT-G over time as a function of dose
Time frame: 10 weeks
Concentration-response relationship of CK-3773274 on left ventricular ejection fraction (LVEF) over 10 weeks of treatment in patients with HCM
Change from baseline in the resting LVEF
Time frame: Day 1 to End of Study (EOS) (Week 14)