Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rejection Heart Transplant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Identification of an extracellular vesicle-derived biomarker or biomarker pattern to diagnose endomyocardial biopsy-proven acute cellular or antibody-mediated cardiac allograft rejection [Time frame: From entrollment to the end of study participation at 15 months]
Eligibility criteria
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:
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Deutsches Herzzentrum der Charité, Department vor cardio-thoracic and vascular surgery — Berlin
Identifiers
NCT: NCT07673536 · 2026-053-CVK · 101137466