NCT07541833招募中不适用
A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Cibenzoline in Japan (MANAGE-HCM)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tapering/Add-on Group
Participants who continue cibenzoline at the initiation of mavacamten treatment
干预措施: Mavacamten (Drug)
Switch Group
Participants who discontinue cibenzoline before or at the initiation of mavacamten treatment
干预措施: Mavacamten (Drug)
结局指标
主要结局
Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment
时间窗: Baseline and up to week 16
次要结局
- Proportion of participants continuing cibenzoline(Baseline and weeks 4, 8, 12, and 16)
- Change in Left Ventricular Outflow Tract (LVOT) peak gradient (resting and Valsalva maneuver)(Baseline and up to week 16)
- Proportion of patients achieving target Left Ventricular Outflow Tract (LVOT) peak gradients (<50 mmHg / <30 mmHg) (Valsalva maneuver or post-exercise)(Baseline and up to week 16)
- Change in systolic function parameters (left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Number of participants with Left Ventricular Ejection Fraction (LVEF) <50% as assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Proportion of patients with any decrease in resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradients(Baseline and up to week 16)
- Proportion of patients with ≥1 New York Heart Association (NYHA) functional class improvement(Baseline and up to week 16)
- Change in cardiac biomarkers from baseline(Baseline and up to week 16)
- Change in left ventricular cardiac output (LVCO) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in early diastolic mitral annular velocity (e') measured at the lateral, septal, and averaged positions from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in E/e' ratio measured at the lateral, septal, and averaged positions and E/A ratio (ratio of early (E) to late (A) ventricular filling velocities) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in cardiac structural dimensions from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in left ventricular outflow tract (LVOT) gradient measured at rest and during Valsalva maneuver from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in cardiac chamber volumes (left ventricular end-diastolic volume, left ventricular end-systolic volume, and left atrial volume) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in indexed cardiac chamber volumes (left ventricular end-diastolic volume index, left ventricular end-systolic volume index, and left atrial volume index) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in left ventricular diameters (left ventricular end-diastolic diameter and left ventricular end-systolic diameter) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in indexed left ventricular diameters (left ventricular end-diastolic diameter index and left ventricular end-systolic diameter index) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in left atrial dimension from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in left ventricular mass index (LVMI) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Number of participants with systolic anterior motion (SAM) of the mitral valve, and number of participants with mitral regurgitation (MR) assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Number of treatment emergent adverse events (TEAEs)/adverse drug reactions (ADRs) and serious TEAEs/ADRs(Up to week 16)
- Proportion of patients who decrease or increase dose and/or frequency of cibenzoline, beta blocker, or calcium channel blocker(Baseline and weeks 4, 8, 12, and 16)
- Daily dose of cibenzoline, beta blocker, or calcium channel blocker(Baseline and weeks 4, 8, 12, and 16)
- Change in Left Ventricular Ejection Fraction (LVEF) as assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
- Change in left ventricular stroke volume (LVSV) from baseline assessed by transthoracic echocardiography (TTE)(Baseline and up to week 16)
研究者
研究点 (1)
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