Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation

NCT07673536 | Recruiting

• 2 other identifiers: 2026-053-CVK101137466
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rejection Heart Transplant

Outcome Measures

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

  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.

  From entrollment to the end of study participation at 15 months

Study Arms (1)

HTx patients

This study will include patients actively listed for heart transplantation (HTx) and patients who are still hospitalized following HTx surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients within the first year after heart transplantation

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laurenz Kopp Fernandes: lead

Study Sites (1)

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

Berlin, State of Berlin, 13353, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood plasma

Study Officials

• Felix Schoenrath, Prof

  Charité Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurenz Kopp Fernandes

CONTACT

+49 (0)30 4593 2154; laurenz.koppfernandes@dhzc-charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

DE (1)