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New heart test could spare transplant patients from risky biopsies

NCT ID NCT06656065

Knowledge-focused Sponsor: Hospital Miguel Servet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new way to monitor heart transplant patients for rejection using a simple catheter-based measurement called IMR. The goal is to see if this test can identify high-risk patients and reduce the need for invasive biopsies. Researchers will follow 100 heart transplant recipients for one year.

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 a safer, less invasive way to monitor heart transplant patients for rejection, potentially reducing the need for risky biopsies.
What could go wrong
This is an observational study, not a treatment trial. It may not change clinical practice if the IMR measurement does not reliably predict rejection or outcomes.

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 100 people

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

Started

May 2023

Expected to finish

Oct 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

Heart trasplant patients that have signed informed consent and meet all inclusion and exclusion criteria for undergoing IMR assessment.

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: * Heart transplant patients \>18 years. * Patients who have received and signed informed consent. Exclusion Criteria: * Patients with hemodynamic instability after HT, including cardiogenic shock or severe coagulopathy. * Patients with acute cellular rejection before intracoronary physiological assessment. * Patients with bronchial asthma or bronchopathy with a positive bronchodilation test, which contraindicates the use of adenosine. * Patients with epicardial coronary lesions with a resting physiological index ≤0.89 or ≤0.80 at hyperemia. * Patients unlikely to cooperate or with inability or unwillingness to give informed consent.

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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 transplant rejection Microvascular resistance

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

  • Hospital Miguel Servet

    RECRUITING

    Zaragoza, Zaragoza, 50009, Spain

  • Hospital Universitario de Bellvitge

    ACTIVE_NOT_RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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