Status:
RECRUITING
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Lead Sponsor:
Inova Health Care Services
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiac Failure
Graft Rejection
Eligibility:
All Genders
18-99 years
Brief Summary
This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and...
Detailed Description
The study objectives will be accomplished in a prospective, multicenter observational, longitudinal cohort study that includes \~250 Heart Transplant patients from the United States. Patients will be ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at enrollment
- Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
- Planned follow-up at the transplant center for a minimum of one-year.
- Patient 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 (e.g., inotrope or vasopressor therapy)
- Ongoing need for renal replacement therapy and/or dialysis
- Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
- Active rejection being treated with intravenous medications or plasmapheresis
Key Trial Info
Start Date :
October 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06939751
Start Date
October 28 2025
End Date
January 1 2032
Last Update
December 17 2025
Active Locations (2)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
2
Inova Health System
Falls Church, Virginia, United States, 22042