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Tiny particles in blood may reveal heart transplant rejection without a biopsy

NCT ID NCT07673536

Diagnosis Sponsor: Laurenz Kopp Fernandes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study looks at whether proteins carried by tiny particles called extracellular vesicles in the blood can signal when a heart transplant is being rejected. Researchers will track 30 heart transplant patients over 15 months, comparing protein patterns in those with and without rejection. The goal is to find a reliable, non-invasive way to diagnose rejection earlier than current methods allow.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
extracellular vesicle protein profiling (diagnostic test)
What this could lead to
If successful, this could lead to a simple blood test to detect heart transplant rejection early, reducing the need for invasive heart biopsies.
What could go wrong
This is a small, early-stage study (30 participants) focused on finding protein patterns, not yet proving the test works in practice. The identified markers may not be reliable enough for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients within the first year after heart transplantation

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rejection heart transplant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Berlin, State of Berlin, 13353, Germany

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