Status:
RECRUITING
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
Lead Sponsor:
Inova Health Care Services
Conditions:
Cardiac Failure
Graft Rejection
Eligibility:
All Genders
Up to 18 years
Brief Summary
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 p...
Detailed Description
The study objectives will be accomplished in a prospective, multicenter observational, longitudinal cohort study that includes 100-150 Pediatric Heart Transplant (PHT) patients from the United States....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06532890
Start Date
February 6 2025
End Date
October 1 2029
Last Update
December 19 2025
Active Locations (6)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Columbia University
New York, New York, United States, 10032
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
4
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232