REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM

Open to people ages 18-70

• Males and females between 18 and 70 years of age at screening.
• Body weight is ≥45 kg at screening.
• Diagnosed with oHCM per the following criteria:
• Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
• Has minimal wall thickness ≥15 mm at time of initial diagnosis (minimal wall thickness ≥13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
• Adequate acoustic windows for echocardiography.
• Has LVOT-G during screening as follows:
• Resting gradient ≥50 mmHg OR
• Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
• LVEF ≥60% at screening.
• New York Heart Association (NYHA) Class II or III at screening.
• Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for >4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study.

• Aortic stenosis or fixed subaortic obstruction.
• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
• History of LV systolic dysfunction (LVEF <45%) at any time during their clinical course.
• Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
• Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period.
• Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening.
• Documented atrial fibrillation during the screening period.
• Paroxysmal atrial fibrillation or flutter requiring treatment (eg, anti-coagulation or antiarrhythmic therapy including disopyramide) documented within the 6 months prior to screening.
• History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
• Has received prior treatment with CK-3773274 or is currently receiving mavacamten.
• Is a CYP2D6 poor metabolizer