Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation
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
- 否
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
Antonella Galeone
MD, PhD
Groupe Hospitalier Pitie-Salpetriere
