๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
โข Signed informed consent form (ICF): Participants, or their legally acceptable representative, must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF in accordance with regulatory, local, and institutional guidelines. This must be obtained before the performance of any protocol-related procedures.
* Diagnosed with obstructive hypertrophic cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below:
* 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 โฅ 15 mm (or โฅ 13 mm with positive family history of HCM).
* Has Left Ventricular Outflow Tract (LVOT) peak gradient โฅ 30 mmHg (resting, Valsalva maneuver, or post-exercise).
* Has documented Left Ventricular Ejection Fraction (LVEF) โฅ 55% at baseline.
* Participants who meet any of the following criteria:
* Participants who have previously received mavacamten continuously for โฅ 16 weeks
* Participants who are currently receiving mavacamten
* Participants who are scheduled to receive mavacamten
* Treated with a stable dose of cibenzoline for at least 3 months prior to initiating mavacamten treatment. Tapered cibenzoline within 3 months prior to initiating mavacamten treatment is allowed if stable dose of cibenzoline was used for at least 3 months prior to tapering.
* At least 18 years of age at the time of signing the informed consent.
Exclusion Criteria:
* 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).
* Severe atrioventricular block or severe sinoatrial block.
* Congestive heart failure.
* Requiring dialysis.
* Angle-closure glaucoma.
* Tendency to urinary retention.
* Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate.
* Mavacamten treatment within 8 weeks prior to baseline. Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient.