Rejection Heart TransplantExoRejeCTNCT07673536
Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation
An observational study of Rejection Heart Transplant, run by Laurenz Kopp Fernandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rejection Heart Transplant
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2026to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients within the first year after heart transplantation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum der Charité, Department vor cardio-thoracic and vascular surgery
Berlin, State of Berlin, 13353
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HTx patients | This study will include patients actively listed for heart transplantation (HTx) and patients who are still hospitalized following HTx surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From entrollment to the end of study participation at 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start18 Jun 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rejection Heart TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laurenz Kopp Fernandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laurenz Kopp Fernandes, Charite University, Berlin, Germany
- Investigators
- Felix Schoenrath, Prof, Principal investigator, Charité Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673536
- Sponsor's protocol ID
- 2026-053-CVK
- Other IDs
- 101137466
- Acronym
- ExoRejeCT
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT07673536
- Acronym / sponsor ID
- ExoRejeCT / 2026-053-CVK
- Conditions
- Rejection Heart Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Laurenz Kopp FernandesUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HTx patients | – | –This study will include patients actively listed for heart transplantation (HTx) and patients who are still hospitalized following HTx surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients within the first year after heart transplantation
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felix Schoenrath, Prof principal investigator
Charité Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rejection Heart Transplant, run by Laurenz Kopp Fernandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurenz Kopp Fernandes (+49 (0)30 4593 2154, laurenz.koppfernandes@dhzc-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.