Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- event-free survival
研究概览
简要总结
In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented CAD evidenced by either coronary angiography (>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction
- •transient ischemia evidenced by abnormalities during an exercise ECG (standard Bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry
排除标准
- •unstable angina pectoris
- •myocardial infarction or coronary revascularization within 3 months of study entry
- •an ECG abnormality interfering with exercise ST-segment interpretation (eg, ST-segment depression >0.5 mm, QRS duration >0.1 second, R-wave amplitude <8 mm,preexcitation,or atrial fibrillation)
- •inability to undergo exercise testing
- •uncontrolled hypertension
- •other serious condition (medical, psychiatric, cognitive, or social)
- •symptoms of sufficient severity (Canadian class II or higher) to require antianginal medications other than nitrates
- •heart failure
- •greater than first-degree atrio-ventricular block, asthma, or other contraindications to betablocker therapy
研究组 & 干预措施
Carvedilol
干预措施: Carvedilol (Drug)
Ivabradine
干预措施: Ivabradine (Drug)
结局指标
主要结局
event-free survival
时间窗: 18 months
primary outcome was event-free survival at 18 months. The following ischemia related events were considered: death, resuscitation from ventricular tachycardia/fibrillation, nonfatal myocardial infarction, hospitalization for unstable angina, aggravation of angina requiring known antianginal therapy, and need for revascularization.
次要结局
未报告次要终点
研究者
Gennaro Cice
Responsible Cardiology Unit ℅ Cappella Cangiani
University of Campania "Luigi Vanvitelli"