OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Recruiting now
Conditions studied: Cardiac Failure, Graft Rejection
In brief
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 levels). These miRs will be used to characterize the overall immune state in adult 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.
Key facts
- Study ID
- NCT06939751
- Run by
- Inova Health Care Services
- People needed
- 250
- Starts
- 2025-10-28
- Expected to finish
- 2032-01-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Vanderbilt University — Nashville, Tennessee, United States (enrolling)
- Baylor University Medical Center — Dallas, Texas, United States (enrolling)
- Inova Health System — Falls Church, Virginia, United States
Full record on ClinicalTrials.gov
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