Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
Recruiting · NCT06532890 · Observational (researchers observe without assigning treatment) · Lead sponsor: Northwestern University
View the official record on ClinicalTrials.gov →What this trial is about
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 can take part
Age range
Up to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
7 locations listed across 7 US states.
- Children's Hospital Colorado - Aurora, Colorado, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago, Illinois, 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