NCT06112743进行中（未招募）4 期
MEMENTO - A Phase 4, Single-arm, Open-label Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 46
- 主要终点
- Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
研究概览
简要总结
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York Heart Association (NYHA) Functional Class II or III].
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:.
- •Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise.
- •Left ventricular ejection fraction (LVEF) ≥ 55% at rest.
- •New York Heart Association (NYHA) functional class II or III symptoms.
排除标准
- •A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM.
- •Documented obstructive coronary artery disease or history of myocardial infarction.
- •A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening.
- •An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR).
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Mavacamten
Experimental
干预措施: Mavacamten (Drug)
结局指标
主要结局
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
时间窗: At week 48
Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment: * A decrease of at least 5 mL/m2 in maximum LAVI from baseline * A decrease of at least 5 g/m2 in LVMI from baseline
次要结局
- TEAEs leading to laboratory abnormalities(Up to 48 weeks)
- Change from baseline in maximum left atrial volume index (LAVI) at Week 48(At week 48)
- Incidence of MACE-expanded events(Up to 48 weeks)
- Incidence of heart failure (HF) events(Up to 48 weeks)
- Incidence of HF events with systolic dysfunction(Up to 48 weeks)
- Change from baseline in left ventricular mass index (LVMI) at Week 48(At week 48)
- Incidence of major adverse cardiac events (MACE)(Up to 48 weeks)
- Incidence of ventricular tachyarrhythmias(Up to 48 weeks)
- Incidence of treatment emergent serious adverse events (SAEs)(Up to 48 weeks)
- Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48(At week 48)
- Incidence of nonvasovagal syncope and seizures(Up to 48 weeks)
- All-cause mortality(Up to 48 weeks)
- TEAEs leading to discontinuation from study intervention(Up to 48 weeks)
- Incidence of atrial fibrillation (AF)/atrial flutter(Up to 48 weeks)
- Incidence of cardiovascular (CV) mortality(Up to 48 weeks)
- Incidence of treatment emergent adverse events (TEAEs)(Up to 48 weeks)
- Severity of TEAEs(Up to 48 weeks)
研究者
研究点 (46)
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