Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation
ConditionRejection Heart Transplant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaurenz Kopp Fernandes
About this trial
This study will analyze extracellular vesicle (EV)-derived protein profiles in heart transplantated patients during the first 15 months post-transplantation to investigate, if there are distinct EV-derived proteins or protein patterns that allow early and reliable diagnosis of acute cardiac allograft rejection. Additionally, it will explore temporal changes in the EV-derived protein profile during the early postoperative period irrespective of acute allograft rejection, and will investigate, if there are correlations between EV protein markers and imaging findings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is either on the heart transplant waiting list or is still hospitalised following HTx surgery.
Age of subject is ≥ 18 years.
Subject is female or male.
Capacity to consent.
Disqualifiers
Concurrent multiple solid organ or tissue transplants.
Prior history of any organ or cellular transplantation.
Subject suffers from an addiction or from a disease that prevents the subject from recognising nature, scope, and consequences of the study.
Subject shows an inability to comply with all the study procedures and follow-up visits.
Trial population
Patients within the first year after heart transplantation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: HTx patients
Trial outcomes
Primary outcomes
1
Identification of an extracellular vesicle-derived biomarker or biomarker pattern to diagnose endomyocardial biopsy-proven acute cellular or antibody-mediated cardiac allograft rejection
Change of the level of at least one EV-derived biomarker in the blood plasma of cardiac allograft recipients with endomyocardial biopsy-proven acute cellular or antibody-mediated cardiac allograft rejection compared to those with no rejection at the time of blood sampling.
Time frame
From entrollment to the end of study participation at 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laurenz Kopp Fernandes
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
Source ClinicalTrials.gov