NCT00170300已完成不适用
Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure
Medtronic Cardiac Rhythm and Heart Failure0 个研究点目标入组 813 人开始时间: 2001年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 813
- 主要终点
- All cause mortality or unplanned cardiovascular hospitalization.
研究概览
简要总结
The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy.
详细描述
813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Heart failure for at least 6 weeks requiring loop diuretics
- •Currently in NYHA class III/IV
- •A high standard of pharmacological therapy
- •LV systolic dysfunction and dilation (EF <=35%; EDD >30mm/height in metres)
- •QRS >=120 ms Dyssynchrony confirmed by echo if QRS 120-149 ms (Aortic pre-ejection delay >140ms, Interventricular mechanical delay >40 ms, Delayed activation of postero-lateral LV wall)
排除标准
- •Age < 18 years old or age < legal age defined in the country in case different
- •Chronic atrial fibrillation within 6 weeks prior to randomization;
- •Impairment of left ventricular function not related to left ventricular systolic function
- •Potentially reversible forms of cardiomyopathy:
- •Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization
- •A conventional indication for bradyarrhythmia pacing exists;
- •A conventional indication for an ICD exists
- •A pacemaker or ICD has already been implanted;
- •In-Patients requiring continuous intravenous therapy for Heart Failure;
- •Life expectancy < 1 year for disease unrelated to Heart Failure;
- •Pregnancy or childbearing potential and not on reliable contraceptive;
- •Mechanical tricuspid valve;
- •Anticipated compliance problem or participation in another trial;
结局指标
主要结局
All cause mortality or unplanned cardiovascular hospitalization.
次要结局
- All cause mortality
- Days alive and not in hospital for any reason
- Days alive and not in hospital for unplanned cardiovascular cause
- HEALTH ECONOMIC OUTCOME:Cost effectiveness of cardiac resynchronization will be assessed.
- All cause mortality or unplanned hospitalization for or with worsening Heart Failure
- NYHA class at 90 days
- End of study status
- MECHANISTIC OUTCOME:Echocardiographic parameters, Neurohormonal parameters, Therapy delivery assessment
- QOL at 90 days
研究者
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