Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased Pump Speed During Sustained Submaximal Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Exercise time
研究概览
简要总结
This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).
The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.
详细描述
To test the hypothesis described above the investigators will study submaximal exercise tests below anaerobic threshold in patients supported with CF-LVADs.Each patient will perform two tests- one with baseline CF-LVAD pump speed and the other with incrementally increased pump speed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.
排除标准
- •Unstable patients, CF-LVAD implantation less than three months ago.
结局指标
主要结局
Exercise time
时间窗: Exercise time will be estimated only on the day of the study. No follow-up.
Exercise will be performed on a upright ergometer bike with simultaneously breath-by-breath gaz analysis.
次要结局
- Perceived exertion(Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.)
研究者
Finn Gustafsson
MD
Rigshospitalet, Denmark