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临床试验/NCT05824364
NCT05824364已完成不适用

Exercise aNd hEArt Transplant

Fondazione Don Carlo Gnocchi ETS3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月20日最近更新:
适应症
干预措施

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

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

Experimental

two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation

干预措施: telerehabilitation (Other)

Case

Experimental

two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation

干预措施: rehabilomic (Other)

Control

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuccia Morici

Head of Cardiac Rehabilitation Department

Fondazione Don Carlo Gnocchi ETS

研究点 (3)

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