OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Inova Health Care Services
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 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.
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 screened for eligibility and enrolled \~1 month (± 2 weeks) after transplant. Study participation will last 36 months. All patients will follow the center's standard of care surveillance schedule after transplant. Blood samples will be collected for miR evaluation at: 1. specified time intervals after transplant and 2. when a clinical event of interest occurs, including treated rejection, or inf…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 t…
Locations (7)
- Cedars-Sinai Medical CenterLos Angeles, California
- Stanford UniversityPalo Alto, California
- Tufts Medical CenterBoston, Massachusetts
- Medical University of South CarolinaCharleston, South Carolina
- Vanderbilt UniversityNashville, Tennessee
- Baylor University Medical CenterDallas, Texas