Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorInova Health Care Services
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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov