NCT01698398已完成不适用
The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Peak oxygen consumption.
研究概览
简要总结
The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.
The study population will consist of severe heart failure patients with CF-LVADs treated at The Heart Centre of Copenhagen University Hospital Rigshospitalet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •HeartMate II patients who underwent surgery and follow-up at The Heart Centre of Rigshospitalet.
- •Heart failure in stable phase without the need for intravenous inotropic therapy.
- •Ischemic and non-ischemic cardiomyopathy.
排除标准
- •Severe aortic insufficiency.
结局指标
主要结局
Peak oxygen consumption.
时间窗: Day 1
ml oxygen/minute/kg
次要结局
- Working capacity.(Day 1)
研究者
研究点 (2)
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