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

NCT ID: NCT03050892

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-05-01

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: 0.05, bilateral).

Conditions

Heart Transplant Failure and Rejection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: lead

Responsible Party

Antonella Galeone

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Thoracic and Cardiovascular Surgery, Cardiac Institute, Groupe Hospitalier La Pitié Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Antonella Galeone, MD, PhD

Role: CONTACT

a.galeone@email.it

0033664841652

Facility Contacts

Antonella Galeone, MD, PhD

Role: primary

a.galeone@email.it

0033664841652

Other Identifiers

CIC-1421-16-01

Identifier Type: -

Identifier Source: org_study_id