The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
175
Aficamten (CK-3773274) tablets administered orally
Placebo for aficamten (CK-3773274) administered orally
Metoprolol succinate tablets administered orally
Change in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
Effect of aficamten compared with metoprolol succinate on exercise capacity in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Exercise capacity was determined through changes in peak oxygen uptake (pVO2) after 24 weeks of treatment. pVO2 was measured by cardiopulmonary exercise testing (CPET) on a treadmill or bicycle. A higher pVO2 indicates better cardiorespiratory fitness.
Time frame: Baseline to Week 24
Proportion of Patients With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class
Effect of aficamten compared with metoprolol succinate on NYHA Functional Classification
Time frame: Baseline to Week 24
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Effect of aficamten compared with metoprolol succinate on participant health status was measured by change in KCCQ-CSS. The KCCQ is a patient-reported outcome designed to assess the physical limitations, symptoms, self-efficacy, quality of life, and social limitation of patients with heart failure symptoms. The CSS is the sum of the physical limitation score and the total symptom score. The KCCQ-Clinical Symptoms Score (KCCQ-CSS) is scored on a scale from 0 to 100, with higher scores indicating better physical functioning and symptoms.
Time frame: Baseline to Week 24
Change in Left Ventricular Mass Index (LVMI)
Effect of aficamten on mass of the heart as compared with metoprolol succinate
Time frame: Baseline to Week 24
Change in Left Atrial Volume Index (LAVI)
Effect of aficamten on size of the heart as compared with metoprolol succinate
Time frame: Baseline to Week 24
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Placebo for metoprolol succinate administered orally
Alaska Heart and Vascular Institute
Anchorage, Alaska, United States
Mayo Clinic
Phoenix, Arizona, United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
AdventHealth
Orlando, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
...and 61 more locations
Change From Baseline Values in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Effect of aficamten on NT-proBNP as compared with metoprolol succinate. For change in NT-proBNP from baseline to Week 24, the log transformed proportional change up to Week 24 was analyzed using a mixed model for repeated measures (MMRM) then the estimate was back transformed to obtain the ratio.
Time frame: Baseline to Week 24
Change in Post-Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)
Effect of aficamten on post-Valsalva LVOT-G as compared with metoprolol succinate
Time frame: Baseline to Week 24