NCT01920048已完成不适用
REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED): a Randomized Comparison of Percutaneous Coronary Intervention (With Optimal Medical Therapy) Versus Optimal Medical Therapy Alone for Treatment of Heart Failure Secondary to Coronary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 40
- 主要终点
- All-cause death or Hospitalization for Heart Failure
研究概览
简要总结
This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.
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
- 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
- •ALL of the following:
- •Poor left ventricular function (EF≤35%)
- •Extensive coronary disease
- •Viability in at least 4 dysfunctional segments that can be revascularised by PCI
排除标准
- •Myocardial infarction < 4 weeks prior to randomisation (clinical definition)
- •Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Balloon Pump/left ventricular assist device therapy <72 hours prior to randomization
- •Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges <72 hours prior to randomization
- •Valve disease requiring intervention
- •Contraindications to percutaneous coronary intervention
- •Age <18 yrs
- •Estimated Glomerular Filtration Rate < 25 ml/min, unless established on dialysis
- •Women who are pregnant
- •Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
- •Life expectancy < 1 yr due to non-cardiac pathology
研究组 & 干预措施
Percutaneous Coronary Intervention and Optimal Medical Therapy
Experimental
干预措施: Percutaneous Coronary Intervention (Procedure)
Percutaneous Coronary Intervention and Optimal Medical Therapy
Experimental
干预措施: Drug Therapy for Heart Failure (Drug)
Percutaneous Coronary Intervention and Optimal Medical Therapy
Experimental
干预措施: Device Therapy for Heart Failure (Device)
Optimal Medical Therapy alone
Active Comparator
干预措施: Drug Therapy for Heart Failure (Drug)
Optimal Medical Therapy alone
Active Comparator
干预措施: Device Therapy for Heart Failure (Device)
结局指标
主要结局
All-cause death or Hospitalization for Heart Failure
时间窗: 1 to 103 months (min follow-up duration: 24 months)
This composite endpoint will be collected over the entire duration of follow-up in the trial when the last patient randomized has reached 2 years of follow-up post randomization
次要结局
- Hospitalization due to heart failure(1 to 103 months (min follow-up duration: 24 months))
- Quality of Life Scores(6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years)
- Left Ventricular Ejection Fraction(6 months, 1 year)
- Cardiovascular Death(1 to 103 months (min follow-up duration: 24 months))
- All-cause death(1 to 103 months (min follow-up duration: 24 months))
- Appropriate Implantable Cardioverter Defibrillator Therapy(6 months, 1 year, 2 years)
- Unplanned further revascularization(1 to 103 months (min follow-up duration: 24 months))
- Canadian Cardiovascular Society class(6 months, 1 year, 2 years)
- Brain-type Natriuretic Peptide level(6 months, 1 year, 2 years)
- New York Heart Association Functional (NYHA) Class(6 months, 1 year, 2 years)
- Acute Myocardial Infarction(1 to 103 months (min follow-up duration: 24 months))
- Major Bleeding(6 months, 1 year, 2 years)
研究者
Divaka Perera
Consultant Cardiologist and Professor of Cardiology
King's College London
研究点 (40)
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