CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).
研究概览
简要总结
The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.
详细描述
In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms
排除标准
- •HOCM intraventricular gradient < 50mmHg
- •LV ejection fraction < 50%
- •mild symptoms
结局指标
主要结局
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).
时间窗: 1 and 2 years
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)
次要结局
- Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade.(1 and 2 years)
研究者
Josep Brugada
Principal Investigator
Hospital Clinic of Barcelona