RECRUITINGOBSERVATIONAL
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (7)
Children's Hospital Colorado
Aurora, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Inova Health System
Falls Church, Virginia, United States