NCT00729222已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With 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
- 60
- 主要终点
- change in pulmonary capillary wedge pressure
研究概览
简要总结
The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.
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 (Participant, Investigator)
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
- •Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg
排除标准
- •Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks
研究组 & 干预措施
2
Experimental
rolofylline
干预措施: rolofylline (Drug)
结局指标
主要结局
change in pulmonary capillary wedge pressure
时间窗: from baseline to 4 and 8 hours
次要结局
- Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure(from baseline to 4 and 8 hours)
研究者
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