Exercise aNd hEArt Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Cardiovascular events
研究概览
简要总结
Registry-based randomized clinical trial (RRCT) to assess the safety and efficacy of two different schemes of exercise training in patients who have recently undergone heart transplantation
详细描述
40 patients who achieved Heart transplantation (HTx) will be randomized in a pilot study to 4 weeks of on-site standard CR (control arm) versus two-four weeks of on-site CR followed by 12 weeks of telerehabilitation (experimental arm). Both surrogate endpoints [cardiometabolic equivalents (Vo2 peak)] and clinical endpoint [primary outcome defined as acute rejection, hospitalization for heart failure, stroke, myocardial infarction, all-cause mortality, at the longest follow-up available (minimum 6-month follow-up)] will be evaluated.
The rehabilomic approach will be applied in order to identify specific patients' phenotype. To identify the potential variations of circulating molecules levels that could be indicators of the rehabilitation outcome and/or progression of the disease, the research team will focus on the analysis of extracellular vesicles (EVs) isolated from the serum of the 40 patients at admission (T0) and after cardiac rehabilitation (T1). In particular, researchers will detect and analyze the relative amount of serum EVs derived from platelets, endothelium, cardiomyocytes, and macrophages, as their levels are reported to be associated with the occurrence of heart failure.
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
- 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
- 是
入选标准
- •All the patients admitted in the on-site CR after HTx
排除标准
- •unable to sign informed consent
研究组 & 干预措施
Case
two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation
干预措施: telerehabilitation (Other)
Case
two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation
干预措施: rehabilomic (Other)
Control
4 weeks of on-site standard CR
干预措施: rehabilomic (Other)
结局指标
主要结局
Cardiovascular events
时间窗: 6-months
Incidence of acute rejection, Rate of hospitalization for heart failure, Incidence of stroke, Incidence of myocardial infarction and incidence of all-cause mortality
次要结局
- extracellular vesicles (EVs) analysis with Surface Plasmon Resonance imaging (SPRi)(up to 4 weeks)
- Vo2 peak(6-months)
- EuroQol 5-Dimension (EQ-5D-5L)(6-months)
- Short Form 36 (SF36)(6-months)
- Hospital Anxiety and Depression Scale (HADS)(6-months)
研究者
Nuccia Morici
Head of Cardiac Rehabilitation Department
Fondazione Don Carlo Gnocchi ETS
