NCT01543854已完成2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Peak change from baseline of PCWP (pulmonary capillary wedge pressure)
研究概览
简要总结
This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart failure. In addition safety and effects on renal function and biomarkers will be assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 87 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized or requiring admission to hospital for management of acute heart failure within the previous 48 hours.
- •Pulmonary wedge pressure above or equal to18 mmHg determined by right heart catheterization
排除标准
- •Systolic blood pressure below 115 mmHg
- •Significant valvular diseases or arrythmias
- •Acute coronary syndrome in previous 45 days
- •Treatment with mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
- •Impaired renal or hepatic function
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
RLX030
Experimental
RLX030 as intravenous infusion for 20 hours
干预措施: RLX030 (Drug)
Placebo
Placebo Comparator
Matching placebo as intravenous infusion for 20 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Peak change from baseline of PCWP (pulmonary capillary wedge pressure)
时间窗: baseline, after 8 and 20 hrs treatment
Measurements will be made using a Swan-Ganz indwelling catheter
Peak change from baseline of CI (cardiac index)
时间窗: baseline, after 8 and 20 hrs treatment
Measurements will be made using a Swan-Ganz indwelling catheter
次要结局
- Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf)(During 20 hours of infusion and 24 hours after stop of infusion)
- Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration(During 20 hours of infusion and 24 hours after stop of infusion)
- Change over time of PCWP (pulmonary capillary wedge pressure)(During 20 hours of infusion and up to 4 hours after stop of infusion)
- Change over time of systemic vascular resistance (SVR)(During 20 hours of infusion and up to 4 hours after stop of infusion)
- Change over time of pulmonary arterial pressure (PAP)(During 20 hours of infusion and up to 4 hours after stop of infusion)
- Change over time of pulmonary vascular resistance (PVR)(During 20 hours of infusion and up to 4 hours after stop of infusion)
- Change over time of pulmonary and peripheral oxygen saturation(During 20 hours of infusion and up to 4 hours after stop of infusion)
- Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)(During 20 hours of infusion and 24 hours after stop of infusion)
- Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)(During 20 hours of infusion and 24 hours after stop of infusion)
- Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)(During 20 hours of infusion and 24 hours after stop of infusion)
- Change over time on calculated creatinine clearance(During 20 hours of infusion and 4 hours after stop of infusion)
- Pharmacokinetics of RLX030: mean residence time (MRT)(During 20 hours of infusion and 24 hours after stop of infusion)
- Central aortic systolic pressure-time curve(During 20 hours of infusion and 24 hours after stop of infusion)
- Number of patients with adverse events, serious adverse events and death(During 20 hours of infusion and 24 hours after stop of infusion)
- Radial augmentation index-time curve(During 20 hours of infusion and 24 hours after stop of infusion)
- Change over time in Diuresis(During 20 hours of infusion and 4 hours after stop of infusion)
研究者
研究点 (1)
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