Extracellular Vesicles to Monitor Heart Transplant Rejection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will analyze EV-derived protein profiles in heart transplant patients during the first 15 months after surgery to see if specific proteins or patterns can indicate early acute rejection. The study will also look at how EV protein profiles change in the early postop period regardless of rejection and whether these markers relate to imaging findings. This observational study will use existing samples and clinical data to explore potential correlations with clinical events and imaging results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Deutsches Herzzentrum der Charité, Department vor cardio-thoracic and vascular surgery
  Berlin, State of Berlin, Germany Recruiting

Study contacts

• Principal investigator: Felix Schoenrath, Prof — Charité Universitaetsmedizin Berlin
• Study coordinator: Laurenz Kopp Fernandes
• Email: laurenz.koppfernandes@dhzc-charite.de
• Phone: +49 (0)30 4593 2154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.