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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050892
Recruitment Status : Unknown
Verified February 2017 by Antonella Galeone, Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Antonella Galeone, Groupe Hospitalier Pitie-Salpetriere

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

Condition or disease
Heart Transplant Failure and Rejection

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).

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation
Actual Study Start Date : February 29, 2016
Estimated Primary Completion Date : March 1, 2017
Estimated Study Completion Date : May 1, 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 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.


Secondary Outcome Measures :
  1. Survival and Rejection and IL-33 [ Time Frame: 1 year ]
    • Compare mean donor IL-33 serum levels in recipients with 30 days events (mortality and graft dysfunction) versus mean donor IL-33 serum levels in recipients without 30 days events.
    • Compare mean donor IL-33 serum levels in recipients with one year events (mortality and / or graft dysfunction) versus mean donor IL-33 serum level in recipients without events.
    • Compare mean IL-33 serum levels of recipients with events (mortality and / or graft dysfunction) at 30 days and 1 year versus mean IL- 33 serum levels of the recipients who had no events at 30 days and 1 year.
    • Compare the mean donor and recipient IL-33 serum levels in recipients with acute graft rejection versus mean donor and recipient IL-33 serum levels in recipients who did not have an acute rejection of the graft during the first year.

  2. Survival and Rejection and sST2 [ Time Frame: 1 year ]
    • Compare mean donor sST2 serum levels in recipients with one year events (mortality and / or graft dysfunction) versus mean donor sST2 serum level in recipients without events.
    • Compare mean sST2 serum levels of recipients with events (mortality and / or graft dysfunction) at 30 days and 1 year versus mean sST2 serum levels of the recipients who had no events at 30 days and 1 year.
    • Compare the mean donor and recipient sST2 serum levels in recipients with acute graft rejection versus mean donor and recipient sST2 serum levels in recipients who did not have an acute rejection of the graft during the first year.


Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart donors and heart recipients
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050892


Contacts
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Contact: Antonella Galeone, MD, PhD 0033664841652 a.galeone@email.it

Locations
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France
Department of Thoracic and Cardiovascular Surgery, Cardiac Institute, Groupe Hospitalier La Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Antonella Galeone, MD, PhD    0033664841652    a.galeone@email.it   
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
More Information
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Responsible Party: Antonella Galeone, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03050892    
Other Study ID Numbers: CIC-1421-16-01
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No