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Observational Study of MicroRNAs in Pediatric Heart Transplant Patients

This study is looking at tiny molecules called microRNAs (miRs) in the blood of children who have received a heart transplant. The goal is to find specific miRs that can help doctors understand how well a child's immune system is working and predict if they might develop an infection or if their body might reject the new heart. By identifying these miRs, researchers hope to create a new blood test that can help manage medications after transplant, reducing the risk of both infection and rejection. Children up to 18 years old who are 10-50 days post-heart transplant can join. This is an observational study, meaning researchers will collect information and blood samples over two years to see how miRs change and relate to health outcomes.

Study design
This is an observational study involving 100-150 pediatric heart transplant patients. It is not specified if it is randomized or blinded.
What's involved
You would have blood samples collected at specific times after transplant and when certain health events occur. Other information like medical history and test results will also be gathered. Your participation will last 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years post-transplant to measure microRNAs predicting infection and rejection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06532890

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

Recruiting
Not specifiedUp to 18Observational
Northwestern University
~150 participants
Updated 2026-08-25 on ClinicalTrials.gov

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients
Measured over up to 2 years post-transplant
+1 more outcome measured

Conditions

Cardiac Failure
Graft Rejection

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Graft rejection lineHeart Failure

NCT06532890

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

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

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Children's Hospital Colorado

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Columbia University

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Texas Children's Hospital

    Houston, Texasstudy coordinator listed

    Recruiting

  • University of Michigan

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • Vanderbilt University

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Palak Shah, MD
[email protected]
312-694-7805
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipientsup to 2 years post-transplant

    A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of infection in heart transplant recipients. Infections are defined as any bacterial, viral, fungal, or opportunistic infection leading to: 1) hospitalization, 2) prescription of antimicrobial therapy, or 3) reduction in immunosuppression.

  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipientsup to 2 years post-transplant

    A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of rejection in heart transplant recipients. Rejection is defined as treated rejection based on 1) endomyocardial biopsy (EMB) pathology, 2) unexplained graft dysfunction, or 3) molecular testing; leading to treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg).