Impact of Donor and Recipient ST2 / IL-33 Pathway After Heart Transplantation — ISIDORE  

Heart Transplant Failure and Rejection Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Heart Transplant Failure and Rejection

• NCT number: NCT03050892
• Study type: Observational
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: Antonella Galeone, MD, PhD
• Phone: 0033664841652
• Email: a.galeone@email.it
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2016
• Completion date: May 1, 2018