[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634603":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Switch Group",null,"Participants who discontinue cibenzoline before or at the initiation of mavacamten treatment",[13],"Drug: Mavacamten",{"label":15,"type":10,"description":16,"interventionNames":17},"Tapering\u002FAdd-on Group","Participants who continue cibenzoline at the initiation of mavacamten treatment",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Mavacamten","According to the product label",[9,15],[25],{"name":26,"affiliation":26,"role":27},"Bristo Myers Squibb","STUDY_DIRECTOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":35,"role":31,"phone":10,"phoneExt":10,"email":10},"First line of the email MUST contain NCT # and Site #.",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":10,"geoPoint":10,"contacts":45},"Mebix. Inc","RECRUITING","Minato-ku","Tokyo","1050001","Japan","JP",[46],{"name":47,"role":31,"phone":10,"phoneExt":10,"email":10},"Minoru Tonogai, Site 0001",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100634603","effectiveness-and-treatment-patterns-of-mavacamten-in-patients-with-obstructive-hypertrophic-cardiomyopathy-in-japan-manage-hcm-100634603",false,"NCT07541833","Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)","A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Cibenzoline in Japan (MANAGE-HCM)","Inclusion Criteria:\n\n• Signed informed consent form (ICF): Participants, or their legally acceptable representative, must have signed and dated an Institutional Review Board (IRB)\u002FIndependent 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.\n\n* Diagnosed with obstructive hypertrophic cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below:\n\n  * 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).\n  * Has Left Ventricular Outflow Tract (LVOT) peak gradient ≥ 30 mmHg (resting, Valsalva maneuver, or post-exercise).\n* Has documented Left Ventricular Ejection Fraction (LVEF) ≥ 55% at baseline.\n* Participants who meet any of the following criteria:\n\n  * Participants who have previously received mavacamten continuously for ≥ 16 weeks\n  * Participants who are currently receiving mavacamten\n  * Participants who are scheduled to receive mavacamten\n* 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.\n* At least 18 years of age at the time of signing the informed consent.\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance or to any of the excipients.\n* During pregnancy and in women of childbearing potential.\n* Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone\u002Fmisoprostol).\n* Severe hepatic impairment (Child-Pugh C).\n* Severe atrioventricular block or severe sinoatrial block.\n* Congestive heart failure.\n* Requiring dialysis.\n* Angle-closure glaucoma.\n* Tendency to urinary retention.\n* Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate.\n* Mavacamten treatment within 8 weeks prior to baseline. Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient.","ALL","18 Years",{"count":60,"type":61},36,"ESTIMATED","OBSERVATIONAL","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",[65],"Cardiomyopathy",[67],"hypertrophic cardiomyopathy (HOCM)","2026-06-25",{"date":70,"type":71},"2026-06-26","ACTUAL",{"date":73,"type":71},"2026-02-05",{"date":75,"type":61},"2026-12-31",{"name":5,"class":6},1]