About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Mavacamten
Treatment groups
Locations
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