Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease.
Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients.
Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients.
Aim:
To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (> 80 bpm)
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis patients
- •Sinus rhythm
- •Pre-dialytic Heart rate > 80 bpm
排除标准
- •Atrial fibrillation/atrial flutter
- •Heart failure
- •Valvular disease
研究组 & 干预措施
Ivabradine
干预措施: Ivabradine (Drug)
Control
干预措施: Placebo (Drug)
结局指标
主要结局
Heart rate
时间窗: 1 year
次要结局
- Number of patients that experienced hypotension(1 year)
研究者
Gennaro Cice
MD
University of Campania "Luigi Vanvitelli"