Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)

Recruiting now

Conditions studied: Cardiomyopathy

In brief

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

Key facts

Study ID

NCT07541833

Run by

Bristol-Myers Squibb

People needed

36

Starts

2026-02-05

Expected to finish

2026-12-31

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≥ 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 meet any of the following criteria:
• Participants who have previously received mavacamten continuously for ≥ 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.

You may not qualify if…

• 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.

Where it is running

• Mebix. Inc — Minato-ku, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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