Learning From Early Aficamten In HCM (LEAF-HCM)

Condition studied

Hypertrophic cardiomyopathy

Investigational medicinal product(s)

Eligibility

Primary endpoint

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

Endpoint detail

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.