Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- heart failure clinical composite score
研究概览
简要总结
Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •NHYA class II-III heart failure
- •ischemic cardiomyopathy
- •ejection fraction of 35% or less
- •QRS interval of 120ms or less
- •evidence of mechanical dyssynchrony as measured on echocardiography
排除标准
- •conventional indication for cardiac pacing
- •persistent atrial fibrillation
- •life expectancy lower than 1 year
研究组 & 干预措施
CRT
The CRT group undergoes implantation of a CRT defibrillator
干预措施: cardiac resynchronization therapy (Procedure)
no-CRT
The no-CRT group receives a dual-chamber defibrillator
结局指标
主要结局
heart failure clinical composite score
时间窗: 12 months
Patients are classified according to a score, which assigns subjects to one of three response groups - improved, worsened, or unchanged. Patients are judged to be worsened if they died or were hospitalized because of worsening heart failure (at any time during the 12 months), or demonstrated worsening in NYHA functional class at their 12-month visit. Patients are judged to be improved if they had not worsened and had demonstrated improvement in NYHA functional class at 12 months. Patients who are not worsened or improved are classified as unchanged.
次要结局
- time to the first heart failure hospitalization or death(up to 30 months)
研究者
Carmine Muto
Electrophysiology and Pacing Unit Director
Ospedale Santa Maria di Loreto Mare