IMPACT-CMH: Impact of Mitral Valve and Subvalvular Abnormalities in Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Change in the highest left ventricular outflow tract (LVOT) Doppler maximal gradient (rest or Valsalva) from baseline to 6 months after initiation of mavacamten
研究概览
简要总结
The objective of this observational study is to evaluate the association between the presence of mitral valvular and/or subvalvular anatomical abnormalities prior to initiation of mavacamten and the hemodynamic response at 6 months in patients with obstructive HCM treated with mavacamten. The secondary objective is to determine the impact of different types of anatomical abnormalities of the mitral valve and subvalvular structures on the hemodynamic and clinical response to mavacamten.
详细描述
A retrospective observational cohort study that analyzes previously collected data and does not involve direct patient participation (methodology MR-004). The clinical and ultrasound parameters included in the protocol are obtained as part of patients' routine care.
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
- •Inclusion Criteria :
- •Age ≥18 years
- •Patients who are informed and consent to participate
- •CMH with significant obstruction (left intraventricular gradient at rest or during Valsalva maneuver ≥ 50 mmHg) and symptomatic (NYHA class 2 or 3)
- •Patients who have started treatment with Mavacamten
排除标准
- •Patients who refuse to participate in this register
结局指标
主要结局
Change in the highest left ventricular outflow tract (LVOT) Doppler maximal gradient (rest or Valsalva) from baseline to 6 months after initiation of mavacamten
时间窗: Baseline and 6 months after initiation of mavacamten
Comparison of the change in LVOT gradient according to the presence or absence of mitral valvular and/or subvalvular anatomical abnormalities at baseline
次要结局
- Change in NYHA functional class(Baseline and 6 months after initiation of mavacamten)