NCT04696900Unknown不适用
Examination of the Effect of Prescribed Cardiac Rehabilitation on Quality of Life, Exercise Capacity and Course of Disease in Patients With Advanced Heart Failure or After Ventricular Assist Device Implantation
German Heart Institute2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Efficacy of exercise training in severe heart failure as assessed by exercise capacity
研究概览
简要总结
This trial will evaluate the effect of prescribed exercise training on quality of life and exercise capacity of patients with advanced heart failure or after ventricular assist device implantation. Furthermore, clinical, laboratory and echocardiographic markers of heart failure, rehospitalization rates and cost-effectiveness will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 >17 years
- •written informed consent
- •chronic end-stage systolic heart failure with or without ventricular assist device
- •clinically stable for at least 6 weeks
- •prescription of cardiac rehabilitation
排除标准
- •addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial
- •lack of knowledge of German to fully understand study information
- •pregnancy, pre-menopausal women
- •participation in the rehabilitation program < 80%
- •contraindications of cardiopulmonary exercise testing on an ergometer
结局指标
主要结局
Efficacy of exercise training in severe heart failure as assessed by exercise capacity
时间窗: after 3, 6 and 12 months
Change of exercise capacity measured by six-minute walking distance in meters
Efficacy of exercise training in severe heart failure as assessed by quality of life
时间窗: after 3, 6 and 12 months
Change of quality of life by Kansas City Cardiomyopathy Questionnaire
次要结局
- Renal function biomarkers: glomerular Filtration rate(after 6 and 12 months)
- Hepatic function biomarkers: transaminases(after 6 and 12 months)
- heart failure biomarkers(after 6 and 12 months)
- Renal function biomarker: Creatinin(after 6 and 12 months)
- Hepatic function biomarkers: gamma-glutamyltransferase(after 6 and 12 months)
- Heart failure Progression: Ejection fractions(after 6 and 12 months)
- rehospitalization rates(12 months before training and 12 months while training)
- Heart failure Progression: Diameters(after 6 and 12 months)
- Heart failure Progression: Aortic Valve opening(after 6 and 12 months)
- Heart failure Progression: Valvular regurgitations(after 6 and 12 months)
研究者
研究点 (2)
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