NCT00048425已完成3 期
Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.
Abbott166 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2002年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 166
- 主要终点
- A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.
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
- •A written informed consent must be obtained for hospitalized male or female patients over 18 years old of age.
- •The eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with IV diuretics.
- •It is allowable for the patients to be treated with IV inotropes and vasodilators.
排除标准
- •The following criteria would exclude the patient from study:
- •invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac re-synchronization),
- •rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate),
- •severe ventricular outflow obstruction,
- •hypotension,
- •uncorrected hypokalemia,
- •CNS (e.g. stroke, TIA),
- •respiratory (e.g. COPD, intubated patients, oral,
- •intravenous or intramuscular steroids),
- •renal insufficiency (e.g. increased serum creatinine, dialysis),
- •hepatic impairment (e.g. significant increase in liver enzymes),
- •decompensation from active infection and acute bleeding (e.g. severe anemia).
- •Female patients of child bearing potential must have a negative pregnancy test and use adequate contraceptive precautions.
- •Also excluded is the use of amrinone and milrinone prior to randomization, a history of hypersensitivity to levosimendan or any of the excipients and previous participation in a clinical trial with any experimental treatment within the last 30 days.
结局指标
主要结局
A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.
次要结局
未报告次要终点
研究者
研究点 (166)
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