Right Ventricular Function After Withdrawal of Phosphodiesterase-5 Inhibitors in Left Ventricular Assist Device Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change from baseline in right ventricular global longitudinal strain
研究概览
简要总结
Refractory right heart failure is common during the postoperative period after left ventricular assist device implantation. Oral phosphodiesterase-5 inhibitors are oft initiated in order to facilitate weaning from the intravenous inotropic substances. following this period many patients continue to receive the same medication in the long term, despite missing data on its therapeutic effect on right ventricular function.We hypothesise that beyond the acute postoperative period no additional benefit from the phosphodiesterase-5 inhibitors exists. The aim of the study is a detailed clinical and echocardiographic assessment of the right ventricular function after discontinuation of the medication in patients pretreated for at least one month after receiving left ventricular assist device.
详细描述
The study aims to assess clinical and echocardiographic measures of right ventricular function before and after discontinuation of the oral phosphodiesterase-5 inhibitor in patients on left ventricular device support. At baseline and after discontinuation of the medication patients will receive a clinical examination and New York Heart Association Classification, echocardiographic assessment of right ventricular function, cardiopulmonary exercise testing, 6 minute walking test and assessment of quality of life. The primary outcome is the change of the quantitative echocardiographic parameters of right ventricular function at follow-up. Secondarily, we aim to assess the change in cardiopulmonary exercise capacity, the 6-minute walking distance and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age >18 y.o.
- •clinically stable, ambulatory heart failure patients on left ventricular assist device support
- •implantation > 1 month before inclusion in the study
- •uninterrupted therapy with an oral phosphodiesterase-5 inhibitor initiated during the early postoperativ period due to right heart failure
排除标准
- •unable to provide written informed consent
- •refusal to provide written informed consent
结局指标
主要结局
Change from baseline in right ventricular global longitudinal strain
时间窗: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Change in right ventricular function from baseline as assessed by global longitudinal strain of the right ventricle on transthoracic echocardiography
次要结局
- Change from baseline in peak oxygen uptake rate(4 weeks after discontinuation of phosphodiesterase-5 inhibitors)
- Change from baseline in 6-minute walking distance(4 weeks after discontinuation of phosphodiesterase-5 inhibitors)
- Change from baseline in the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire(4 weeks after discontinuation of phosphodiesterase-5 inhibitors)
研究者
Maria Papathanasiou
Principal Investigator, Cardiologist
University Hospital, Essen