Learning From Early Aficamten In HCM (LEAF-HCM)

Hypertrophic cardiomyopathy

Change in post-Valsalva LVOT-G from baseline to Week 54

Change in LAVI, maximal LV wall thickness, LV mass index, LGE percentage by cMRI from baseline to Week 54, Change in SUV by FAPI-PET/CT scan from base-line to Week 54, Change from baseline to Week 54 in echocar-diographic measurements of cardiac structure and of systolic function including: • Left ventricular ejection fraction • Left ventricular end-systolic and end-diastolic volumes (LVESV and LVEDV, re-spectively) • Left atrial volume, Change in biomarkers (NT-proBNP, hsTnT) from baseline to Week 18 and Week 54, Assessed by analysing change in incidence of heart failure, as defined by: • Change in NYHA class to NYHA class 2 or higher at week 18 and Week 54. • Incidence of an official diagnosis of heart failure during the study (at week 54). • Incidence of indicators that correspond with disease progression, such as: atrial fibrillation, indication for septal reduction therapy, ventricular arrhythmias, death., Assessed by incidence of: • reported major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, heart failure hospitalization, and other CV hospitalization). • left ventricular ejection fraction (LVEF) <50% with or without heart failure symptoms.

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