Rejection Heart Transplant
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Laurenz Kopp Fernandes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Signed written informed consent. * For female subjects: 1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or 2. If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before inclusion.
Exclusion criteria
* 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. * Subject is legally detained in an official institution. * Subjects who are unwilling to consent to saving and propagation of pseudonymised medical data for study reasons. * Subject is financially dependent on the investigators or the study site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of an extracellular vesicle-derived biomarker or biomarker pattern to diagnose endomyocardial biopsy-proven acute cellular or antibody-mediated cardiac allograft rejection | From entrollment to the end of study participation at 15 months | 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. |
Countries
Germany
Contacts
CONTACTLaurenz Kopp Fernandes
PRINCIPAL_INVESTIGATORFelix Schoenrath, Prof
Charité Universitaetsmedizin Berlin
Outcome results
None listed