OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Recruiting · NCT06939751 · 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 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.
Who can take part
Age range
18 Years to 99 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 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 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 (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
6 locations listed across 5 US states.
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Stanford University - Palo Alto, California, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Vanderbilt University - Nashville, Tennessee, United States
- Baylor University Medical Center - Dallas, Texas, United States