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A Needle-Free future for kids after heart transplants?

NCT ID NCT07770659

Knowledge-focused Sponsor: Vanderbilt University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study looks at whether cardiac MRI and blood tests can detect acute rejection in children and young adults who have had a heart transplant. Currently, doctors often use invasive heart biopsies to check for rejection, which can be uncomfortable and risky. The goal is to see if these non-invasive methods could be a reliable alternative, potentially reducing the number of biopsies needed.

What this could mean

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

Active substance
Cardiac MRI and blood tests (cell-free DNA) as non-invasive alternatives to heart biopsies
What this could lead to
If successful, this could reduce the need for invasive heart biopsies in pediatric heart transplant patients, making rejection monitoring safer and less stressful.
What could go wrong
This is an observational study, so it won't directly test a treatment. The accuracy of these non-invasive methods is still uncertain and may not fully replace biopsies.

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 200 people

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

Started

Mar 2023

Expected to finish

Jun 2027

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

Pediatric heart transplant recipients undergoing endomyocardial biopsy either for concerns of rejection or for routine surveillance.

Ages

6 to 25 years

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: * Received heart transplant at age \< 21 years old * \> 2 months from transplant * ≥6 years old and ≤ 25 years old and able to undergo cardiac MRI (CMR) * CMR can be scheduled within 5 days from heart biopsy\* * Heart catheterization with biopsy is scheduled "for cause" to confirm suspected AR or Heart catheterization with biopsy is scheduled for surveillance Exclusion Criteria: * No endomyocardial biopsy scheduled * Other illness or disease process that could potentially lead to myocardial edema or fibrosis * Contraindication to CMR with contrast * Previously enrolled in this study, UNLESS previous enrollment was heart biopsy scheduled for surveillance with no suspicion of AR AND final study status was documented as "no AR" AND current enrollment is heart biopsy is scheduled "for cause" to confirm suspected AR * Multiple transplanted organs * Requires anesthesia for CMR

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Conditions

The condition(s) this trial relates to.

acute transplant rejection Rejection, Psychology transplant rejection

As listed by the trial registrant

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

Cardiac mri Cell free DNA Heart transplant Pediatric heart transplant Rejection

How to take part

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

  1. The places running it

    22 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

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    RECRUITING

    Denver, Colorado, 13123, United States

  • Children's Hospital of Atlanta

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Children's Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Joe DiMaggio Children's Hospital

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Lucile Packard Children's Hospital at Stanford

    RECRUITING

    Palo Alto, California, 94304, United States

  • Lurie Children's Hospital

    RECRUITING

    Chicago, Illinois, 02115, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Mount Sinai Kravis Children's Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Rady Children's Hospital

    RECRUITING

    San Diego, California, 92123, United States

  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UT Health Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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