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New study aims to spot heart transplant rejection without a biopsy

NCT ID NCT06774365

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 683 heart transplant patients to see if advanced heart scans (CMR) and blood tests can detect antibody-mediated rejection, a common complication. Participants must be stable and at least one year post-transplant. The goal is to find non-invasive ways to diagnose rejection earlier and more accurately.

What this could mean

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

What this could lead to
If successful, this could lead to better, non-invasive ways to detect rejection in heart transplant patients, reducing the need for biopsies.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. Results may not change current practices if imaging or biomarkers prove unreliable.

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 683 people

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

Started

Nov 2024

Expected to finish

Dec 2029

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

Clinically stable adult heart transplanted patients will be consecutively enrolled during the routinely outpatient evaluation in the participating centers after IRB approval. Heart Failure and Transplant Unit of IRCCS AOUBO will be the project leader and coordinate the overall study. The investigators plan a one year period for the enrollment and eight months for the follow-up. Patients will be treated and followed according to the routinary clinical practice of each participating center.

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: * Age \> 18 years * Post heart transplantation follow-up between 1 and 15 y * Ambulatory clinical stable * Left ventricular ejection fraction (LVEF) \> 40% (as assessed by complete cardiac ultrasound within 3 months before the enrolment) Exclusion Criteria: * Unplanned hospitalization for cardiovascular causes in the previous three months * Biopsy-proven cellular (2R or greater) or AMR (pAMR\> 1 ) in the previous 3 months * Any contraindication to CMR * Known pregnancy

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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.

Heart transplantation HLA antigens 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

    4 sites. 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

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Milano, 20162, Italy

  • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

    NOT_YET_RECRUITING

    Bari, Bari, 70120, Italy

  • Azienda Ospedaliera dei Colli

    RECRUITING

    Naples, Napoli, 80131, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, Bologna, 40138, Italy

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