Urinary Proteomics in Predicting Heart Transplantation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 352
- 主要终点
- Cardiovascular events
研究概览
简要总结
uPROPHET aims to validate urinary proteomics for risk stratification and monitoring graft performance is recipients of heart transplants
详细描述
The proof of concept underlying uPROPHET rests on the EPLORE findings that capillary electrophoresis coupled with high-resolution mass-spectroscopy reproducibly identified unique urinary proteomic (UP) signatures associated with subclinical left ventricular dysfunction, renal impairment and adverse cardiovascular outcomes. Consensus criteria currently applied for the selection of patients for heart transplantation (HTx) leave an inconvenient margin of uncertainty, because of the unpredictable course of the disease and the shortage of donor hearts. Furthermore, monitoring graft function and adjusting immunosuppression remain major challenges after HTx. Endomyocardial biopsies, up to 20 in the first year after HTx, are the standard approach to detect graft rejection, but require an invasive risk-carrying procedure. uPROPHET aims to develop UP profiling: (1) as a prognostic tool helpful in selecting terminally ill heart failure patients for HTx with the greatest probability of survival while adding a maximum of high-quality years to life; and (2) as an instrument to monitor graft performance and immune system activity and to manage immunosuppression. The new UP classifiers will be initially validated by demonstrating analogy between the proteomic profiles in urine and tissue samples of explanted hearts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage heart failure resistant to treatment
排除标准
- •According to guidelines (J Heart Lung Transplant 2010;29:717-27 and J Heart Lung Transplant 2016; 35: http://dx.doi.org/10.1016/j.healun.2015.10.023).
结局指标
主要结局
Cardiovascular events
时间窗: Patients were followed up from the date of first urine sampling until death or censoring on the date of the last available follow-up visit (median 4 years). Events will be reported at study completion.
This endpoint is available in the hospital records
次要结局
- Graft performance(Patients were followed up from the date of first urine sampling until death or censoring on the date of the last available follow-up visit (median 4 years). Events will be reported at study completion.)