Heart Transplant Failure and RejectionISIDORENCT03050892
Impact of Donor and Recipient ST2 / IL-33 Pathway After Heart Transplantation
An observational study of Heart Transplant Failure and Rejection, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day recipient mortality in order to improve graft screening. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Transplant Failure and Rejection
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Feb 2016to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart donors and heart recipients
Who may be able to join
- Consenting recipients
- Consenting donors to organ/tissue donation for the purpose of scientific research
Who cannot join
- Non consenting recipients
- Non consenting donors to organ/tissue donation for the purpose of scientific research
- Multi-organ transplantation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Thoracic and Cardiovascular Surgery, Cardiac Institute, Groupe Hospitalier La Pitié Salpêtrière
Paris, 75013
Antonella Galeone, MD, PhD, 0033664841652, a.galeone@email.it
About this study
Official title: Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation
Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day recipient mortality in order to improve graft screening.
Read the 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
- Medical subject headings
- Rejection, Psychology
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
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.
Measured: 30 days
Secondary outcomes (2)
Survival and Rejection and IL-33
- 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.
Measured: 1 year
Survival and Rejection and sST2
- 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start29 Feb 2016
- Primary completion1 Mar 2017 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant Failure and RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonella Galeone, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050892
- Sponsor's protocol ID
- CIC-1421-16-01
- Acronym
- ISIDORE
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation
- ClinicalTrials.gov ID
- NCT03050892
- Acronym / sponsor ID
- ISIDORE / CIC-1421-16-01
- Conditions
- Heart Transplant Failure and Rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 1 Mar 2017 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart donors and heart recipients
Key inclusion criteria (2 listed)
- Consenting recipients
- Consenting donors to organ/tissue donation for the purpose of scientific research
Key exclusion criteria (3 listed)
- Non consenting recipients
- Non consenting donors to organ/tissue donation for the purpose of scientific research
- Multi-organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Survival and Rejection and IL-33
Time frame: 1 year
Survival and Rejection and sST2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Failure and Rejection, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Galeone, MD, PhD (0033664841652, a.galeone@email.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.