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About
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
Enrollment
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Inclusion criteria
Participants who meet all the following criteria at screening may be included in the trial:
Males and females between 18 to 85 years of age, inclusive, at screening
Body mass index < 35 kg/m2
Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography -
Has left ventricular (LV) hypertrophy with 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:
NYHA class II or III
Has a screening echocardiogram with the following determined by the echocardiography core laboratory:
Hemoglobin ≥ 10g/dL
Patients previously exposed to mavacamten are allowed to participate but must be off mavacamten for at least 8 weeks
Exclusion criteria
Any of the following criteria will exclude potential participants from the trial:
Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM
History of intolerance or medical contraindication to beta blocker therapy
Resting SBP of > 160 mmHg
Resting heart rate of > 100 bpm
Significant valvular heart disease
Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
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)
Documented room air oxygen saturation reading < 90% at screening
Planned septal reduction treatment that cannot be deferred during the trial period
History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening
History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed.
Current or recent (< 4 weeks) therapy with disopyramide
History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
Has received prior treatment with aficamten or previously intolerant (reduced LVEF requiring permanent drug discontinuation) to mavacamten
Primary purpose
Allocation
Interventional model
Masking
170 participants in 2 patient groups
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Central trial contact
Cytokinetics MD
Data sourced from clinicaltrials.gov
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