Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM

Exclusion Criteria

• •Significant valvular heart disease (per Investigator judgment)
• •* Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
• •* Moderate or severe mitral regurgitation
• •Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
• •Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction.
• •History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy
• •Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
• •Documented room air oxygen saturation reading \< 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
• •History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening
• •History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)
• •Screening diastolic blood pressure ≥ 100 mmHg
• •Received prior treatment with aficamten
• •Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening)
• •Undergone septal reduction therapy \< 6 months prior to screening
• •Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period
• •Paroxysmal or permanent atrial fibrillation is excluded only if:
• •* rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to screening
• •* rate control and anticoagulation have not been achieved for at least 3 months prior to screening.