EUCTR2011-000833-35-PL进行中（未招募）不适用
A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients admitted to hospital or who require admission to hospital for management of acute heart failure with shortness of breath at rest or minimal exertion
- •- stabilized within 2 days after admission
- •- normal or elevated systolic blood pressure
- •- elevated pulmonary capilary wedge pressure measured by Swan-Ganz catheterization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •- severe renal impairment
- •- significant liver impairment defined as hepatic encephalopathy of any degree or total bilirubin > 50 µmol/l (3 mg/dl) or, if patient is not on warfarin therapy, INR > 2.0 (or Prothrombin Time > 2 * ULN)
- •- significant lung impairment
- •- significant heart valve dysfunction or arrythmias
- •- myocardial infarction or acute coronary syndrome within th elast 45 days
研究者
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