Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)
- Conditions
- Cardiac FailureGraft Rejection
- Registration Number
- NCT06532890
- Lead Sponsor
- Inova Health Care Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria:<br><br> - Age = 18 years at enrollment<br><br> - Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks<br><br> - Planned follow-up at the transplant center for a minimum of one-year.<br><br> - Caregiver able and willing to comply with the study visit schedule, study<br> procedures, and study requirements.<br><br>Exclusion Criteria:<br><br> - Recipient of a multi-organ transplant<br><br> - History of prior solid organ transplant before the index heart transplant<br><br> - Ongoing mechanical circulatory support or hemodynamic instability<br><br> - Active infection requiring either a) hospitalization b) treatment with antimicrobial<br> therapy or c) reduction in immunosuppression<br><br> - History of rejection prior to enrollment<br><br> - Inability to collect specified blood volume at enrollment +/- 1 week
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients;Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients
- Secondary Outcome Measures
Name Time Method