Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Card… (NCT07541833) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)
Japan36 participantsStarted 2026-02-05
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
• 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 …
What they're measuring
1
Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment
Timeframe: Baseline and up to week 16
Trial details
NCT IDNCT07541833
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2026-12-31
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com