NCT00130884已完成2 期
Effects of Peroral Levosimendan in the Prevention of Further Hospitalisations in Patients With Chronic Heart Failure. A Randomised, Phase II, Double-Blind, Placebo-Controlled, Multi-Centre, Parallel-Group Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Composite endpoint measuring symptoms, morbidity, mortality
研究概览
简要总结
The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.
详细描述
The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.
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
- •Diagnosed chronic heart failure
- •Severe symptoms (NYHA IIIb-IV)
- •Optimal on-going oral treatment for HF
- •Left ventricular ejection fraction less than or equal to 30%
排除标准
- •Severe obstruction of ventricular outflow tracts
- •Acute myocardial infarction within 30 days before screening
- •Cardiac surgery or coronary angioplasty within 30 days before screening
结局指标
主要结局
Composite endpoint measuring symptoms, morbidity, mortality
次要结局
未报告次要终点
研究者
研究点 (2)
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Effects of peroral levosimendan in the prevention of further hospitalisations in patients with chronic heart failure. A randomised, double-blind, placebo-controlled, multi-centre, parallel-group study - PERSISTCardiac FailureMedDRA version: 7.1Level: LLTClassification code 10007554EUCTR2004-004225-10-EEOrion Pharma300
进行中（未招募）
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Effects of peroral levosimendan in the prevention of further hospitalisations in patients with chronic heart failure. A randomised, double-blind, placebo-controlled, multi-centre, parallel-group study - PERSISTEUCTR2004-004225-10-LTOrion Pharma300
进行中（未招募）
不适用
Effects of peroral levosimendan in the prevention of further hospitalisations in patients with chronic heart failure. A randomised, double-blind, placebo-controlled, multi-centre, parallel-group study - PERSISTCardiac FailureMedDRA version: 7.1Level: LLTClassification code 10007554EUCTR2004-004225-10-LVOrion Pharma300
进行中（未招募）
不适用
Effects of peroral levosimendan in the prevention of further hospitalisations in patients with chronic heart failure. A randomised, double-blind, placebo-controlled, multi-centre, parallel-group study - PERSISTCardiac FailureMedDRA version: 7.1Level: LLTClassification code 10007554EUCTR2004-004225-10-FIOrion Pharma300