Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation
Laurenz Kopp Fernandes
30 participants
Jun 18, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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:
- Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
- If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before inclusion.
Exclusion Criteria7
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07673536