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Observational Study on MicroRNA Levels After Heart Transplant

This study is looking at how tiny molecules called microRNAs (miRs) in your blood can help doctors understand your immune system after a heart transplant. The goal is to find a way to predict if you might get an infection or if your body might reject the new heart. Researchers will collect blood samples at different times after your transplant and when you have certain medical events. They will also gather information about your health, medications, and other tests. This information will help them develop a blood test to better monitor heart transplant patients, aiming to prevent complications like infection or rejection. This is an observational study, meaning you will receive standard care, and researchers will collect data. The study is currently unclear on its recruitment status.

Study design
This is a multicenter observational study involving about 250 heart transplant patients. It is not a randomized or blinded study.
What's involved
You would participate for 36 months, with blood samples collected at specified times and during clinical events. Other data like medical history and test results will also be gathered.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years after their heart transplant to assess microRNA levels.

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

NCT06939751

OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

Recruiting
Not specifiedAges 18–99Observational
Northwestern University
~250 participants
Updated 2026-08-11 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 6 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 3 years post - transplant
+1 more outcome measured

Conditions

Cardiac Failure
Graft Rejection

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NCT06939751

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor University Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolinastudy coordinator listed

    Recruiting

  • Stanford University

    Palo Alto, Californiastudy coordinator listed

    Recruiting

  • Tufts Medical Center

    Boston, Massachusettsstudy 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 enrollment
Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
Planned follow-up at the transplant center for a minimum of one-year.
Patient 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 (e.g., inotrope or vasopressor therapy)
Ongoing need for renal replacement therapy and/or dialysis
Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
Active rejection being treated with intravenous medications or plasmapheresis

What this trial measures

  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipientsup to 3 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 3 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). EMB Pathology: Acute Cellular Rejection (ACR) Grade ≥ 2R and/or Antibody-mediated Rejection (AMR) Grade ≥ pAMR1, per International Society for Heart and Lung Transplantation (ISHLT) grading systems. Graft Dysfunction: Left Ventricular Ejection Fraction (LVEF) decline ≥ 10% from baseline and \< 50% absolute LVEF by echocardiography. Molecular Testing: Presence of 2 of the following 3 criteria-presence of HLA-DSA, elevated donor-derived cell-free DNA (dd-cfDNA), or gene expression results from blood or EMB testing.