Ignite Creation Date:
2024-05-06 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03050892
Status:
UNKNOWN
Last Update Posted:
2017-02-13
First Post:
2017-02-05
Brief Title:
Impact of Donor and Recipient ST2 IL-33 Pathway After Heart Transplantation
Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Organization:
Groupe Hospitalier Pitie-Salpetriere
Study Overview
Official Title:
Impact of Donor and Recipient ST2 IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISIDORE
Brief Summary:
Evaluate the association between donor soluble protein ST2 sST2 serum levels and 30-day recipient mortality in order to improve graft screening
Detailed 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 005 bilateral
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 005 bilateral
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None