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临床试验/NCT03050892
NCT03050892Unknown不适用

Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation

Groupe Hospitalier Pitie-Salpetriere1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年2月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Survival

研究概览

简要总结

Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day recipient mortality in order to improve graft screening.

详细描述

Soluble protein sST2 has recently become a prognostic biomarker in the context of acute myocardial infarction and chronic heart failure, and recent studies also show that sST2 is involved in acute rejection of the cardiac graft in recipients. Experimental studies confirm that the ST2 / IL-33 pathway is involved in the process leading to cardiac transplant rejection in animals. In particular, administration of IL-33 would have a positive effect on pre-clinical cardiac graft survival. No study have looked at the level of ST2 / IL-33 of the donor, with the purpose that it might reflect the condition of the transplanted heart and its initial level of Immune tolerance and maybe predict the risk of subsequent dysfunction.

In this non-interventional study, several blood samples will be taken on donors before organ procurement and on recipients prior to grafting, on day 7 and at the time of each myocardial biopsy (approximately 16 myocardial biopsies the first year). Serum level of sST2 and IL-33 will then be determined according to the ELISA method on each blood sample.

Fifty consecutive couple donors/ recipients will be included in the study. This number of subjects is calculated to detect a doubling of the donor sST2 level between the two recipient groups with 30-day mortality and without mortality (potency: 90%, alpha risk: 0.05, bilateral).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consenting recipients
  • Consenting donors to organ/tissue donation for the purpose of scientific research

排除标准

  • Non consenting recipients
  • Non consenting donors to organ/tissue donation for the purpose of scientific research
  • Multi-organ transplantation

结局指标

主要结局

Survival

时间窗: 30 days

Compare mean donor sST2 serum levels in recipients who died at 30 days versus mean donor sST2 serum levels in recipients who survived at 30 days.

次要结局

  • Survival and Rejection and IL-33(1 year)
  • Survival and Rejection and sST2(1 year)

研究者

发起方
Groupe Hospitalier Pitie-Salpetriere
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonella Galeone

MD, PhD

Groupe Hospitalier Pitie-Salpetriere

研究点 (1)

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