Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorNorthwestern University
About this trial
This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients
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 frame
up to 2 years post-transplant2
Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients
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).
Time frame
up to 2 years post-transplantSponsors and contacts
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Source ClinicalTrials.gov