OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorInova Health Care Services
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
7California
Cedars-Sinai Medical Center90048, Los Angeles United States
Stanford University94304, Palo Alto United States
Massachusetts
Tufts Medical Center02111, Boston United States
South Carolina
Medical University of South Carolina29425, Charleston United States
Sponsors and collaborators
Inova Health Care Services
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov