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NCT Number: NCT07673536

Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum der Charité, Department vor cardio-thoracic and vascular surgery

Berlin, State of Berlin, 13353, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurenz Kopp Fernandes

CONTACT

[email protected]

+49 (0)30 4593 2154

Sponsors and collaborators

Lead sponsor

Laurenz Kopp Fernandes

Other

Registry information

Acronym: ExoRejeCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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