MavAcamten Real World eVidEnce coLlaboration in HCM (MARVEL-HCM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- New York Heart Association (NYHA) functional class
研究概览
简要总结
The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥ 18 years at the index date
- •Prescription of mavacamten for the treatment of Obstructive hypertrophic cardiomyopathy (oHCM) with NYHA Class II or III
- •≥ 12 weeks of follow-up after prescription of mavacamten, except for the baseline data reporting
排除标准
- •Data collection as part of a clinical trial during the study period
- •Participation in a myosin inhibitor clinical trial
研究组 & 干预措施
Participants receiving treatment mavacamten
干预措施: Mavacamten (Drug)
结局指标
主要结局
New York Heart Association (NYHA) functional class
时间窗: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index
Left ventricular outflow tract (LVOT) gradient and associated parameters
时间窗: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index
Left ventricular ejection fraction (LVEF) and associated parameters
时间窗: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index
次要结局
- Mavacamten dose at initiation(Day 1)
- Mavacamten dose change(Up to 72 weeks)
- Reason for mavacamten dose change(Up to 72 weeks)
- Reason for mavacamten permanent discontinuation(Up to 72 weeks)
- Other cardiovascular-related treatments prescribed(Up to 72 weeks)
- Reason for treatment interruption(Up to 72 weeks)
- Prior Obstructive hypertrophic cardiomyopathy (oHCM) therapies(Baseline)
- Concurrent Obstructive hypertrophic cardiomyopathy (oHCM) therapies(Up to 72 weeks)