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Tiny RNA clues could help kids avoid heart transplant complications

NCT ID NCT06532890

Knowledge-focused Sponsor: Northwestern University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 5 times

Summary

This study is looking at tiny molecules called microRNAs in the blood of children who have had a heart transplant. The goal is to find patterns that can predict which children are at risk for infection or rejection of the new heart. By understanding these patterns, doctors hope to better tailor immunosuppressive drugs to each child, improving their long-term health. The study will follow 150 children for at least one year after their transplant.

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 ways to monitor and adjust immunosuppression in children after heart transplant, potentially reducing infections and rejections.
What could go wrong
This is an observational study, not testing a new treatment. It may not directly improve outcomes, and the findings might not apply to all patients or lead to immediate changes in care.

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 150 people

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

Started

Feb 2025

Expected to finish

Oct 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

Patients ≤ 18 years of age at time of transplant listing from geographically and socioeconomically diverse regions of the U.S. who have undergone orthotopic heart transplant (OHT). Patients will be screened for eligibility and enrolled 10-50 days after pediatric heart transplantation.

Ages

Up to 18 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: * Age ≤ 18 years at time of transplant listing * Subject is within 10-50 days post-orthotopic heart transplant at time of enrollment. * Planned follow-up at the transplant center for a minimum of one-year. * Caregiver able and willing to comply with the study visit schedule, study procedures, and study requirements. Exclusion Criteria: * Recipient of a multi-organ transplant * History of prior solid organ transplant before the index heart transplant * Ongoing mechanical circulatory support or hemodynamic instability after transplant * Active infection requiring either a) hospitalization or b) treatment with antimicrobial drugs (does not include prophylaxis for infection or suppressive antibiotics given after transplant) * History of treated rejection prior to study enrollment * Inability to collect specified blood volume after enrollment and prior to 50 days post-transplant

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Conditions

The condition(s) this trial relates to.

heart failure transplant rejection

As listed by the trial registrant

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

Cardiac failure Graft rejection

How to take part

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

  1. The places running it

    7 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

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

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