The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan
Has unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (e.g., hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM).
Has Left Ventricular Outflow Tract (LVOT) peak gradient ≥ 30 mmHg (resting, Valsalva maneuver, or post-exercise).
Has documented Left Ventricular Ejection Fraction (LVEF) ≥ 55% at baseline.
Participants who have previously received mavacamten continuously for ≥ 16 weeks
Hypersensitivity to the active substance or to any of the excipients.
During pregnancy and in women of childbearing potential.
Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone/misoprostol).
Severe hepatic impairment (Child-Pugh C).
The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) who have been prescribed mavacamten treatment by the treating physician as part of routine clinical care, in Japan
Cohort
Other
Mavacamten
DrugAccording to the product label
Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment
Change in Left Ventricular Outflow Tract (LVOT) peak gradient (resting and Valsalva maneuver)
Proportion of patients achieving target Left Ventricular Outflow Tract (LVOT) peak gradients (<50 mmHg / <30 mmHg) (Valsalva maneuver or post-exercise)
Proportion of patients with any decrease in resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradients
Proportion of patients with ≥1 New York Heart Association (NYHA) functional class improvement
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