Effects Of Telmisartan Added To Angiotensin Converting Enzyme Inhibitors On Mortality And Morbidity In Haemodialysed Patients With Chronic Heart Failure: A Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 2
- 主要终点
- all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
研究概览
简要总结
Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population.
Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with ACE inhibitors.
Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5 months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF hospitalization.
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
- Double
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
- •Adult haemodialysis patients with CHF;
- •New York Heart Association (NYHA) class II and III;
- •Ejection fraction less or equal to 40% determined within 6 months; and
- •Therapy with ACE inhibitors individually optimized and unchanged for 30 days before randomization
排除标准
- •Hypotension during dialysis;
- •Atrial fibrillation;
- •Intolerant to low dose of telmisartan
结局指标
主要结局
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
时间窗: 36 months
次要结局
- acute non-fatal myocardial infarction(36 months)
- combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)(36 months)
- cardiovascular hospital admission(36 months)
- nonfatal stroke(36 months)
- coronary revascularization(36 months)
- permanent premature treatment withdrawals(36 months)