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OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

RECRUITINGSponsored by Inova Health Care Services
Actively Recruiting
SponsorInova Health Care Services
Started2025-10-28
Est. completion2031-01-01
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations5 sites

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

Age: 18 Years – 99 YearsHealthy volunteers accepted
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

Conditions3

Cardiac FailureGraft RejectionHeart Disease

Locations5 sites

California

1 site
Stanford University
Palo Alto, California, 94304

South Carolina

1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
Melissa Amitranoamitrano@musc.edu

Tennessee

1 site
Vanderbilt University
Nashville, Tennessee, 37232

Texas

1 site
Baylor University Medical Center
Dallas, Texas, 75246

Virginia

1 site
Inova Health System
Falls Church, Virginia, 22042
Michaela Ramandanes, MPH703-446-6466michaela.ramandanes@inova.org

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