Hypertrophic obstructive cardiomyopathy
Conditions
Interventions
None listed
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form (ICF): Patients, 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. 2.Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below: i.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). ii.Has LVOT peak gradient >= 30 mmHg (resting, Valsalva maneuver, or post-exercise). 3.Has documented LVEF >= 55% at baseline. 4.Patients who meet any of the following criteria: i.Patients who have previously received mavacamten continuously for >= 16 weeks ii.Patients who are currently receiving mavacamten iii.Patients who are scheduled to receive mavacamten 5.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. 6.At least 18 years of age at the time of signing the informed consent.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to the active substance or to any of the excipients. 2.During pregnancy and in women of childbearing potential. 3.Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone/misoprostol). 4.Severe hepatic impairment (Child-Pugh C). 5.Severe atrioventricular block or severe sinoatrial block. 6.Congestive HF. 7.Requiring dialysis. 8.Angle-closure glaucoma. 9.Tendency to urinary retention. 10.Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate. 11.Mavacamten treatment within 8 weeks prior to baseline. 12.Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in either resting or Valsalva LVOT peak gradient whichever used to judge the initiation of mavacamten treatment | — |
Countries
Japan
Contacts
Public ContactKobayashi Rina
Mebix, Inc. Research Promotion Headquarters
Outcome results
None listed