RecruitingNCT06939751

OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

Sponsor

Inova Health Care Services

Enrollment

250 participants

Start Date

Oct 28, 2025

Study Type

OBSERVATIONAL

Conditions

Cardiac Failure Graft Rejection

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

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 Criteria6

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

Locations(5)

Stanford University

Palo Alto, California, 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

Inova Health System

Falls Church, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06939751

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