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OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

NCT06939751 · Inova Health Care Services
In plain English

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About this study
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 infection. Research samples will be collected and used to evaluate miR expression as well as other biomarkers related to heart transplantation and immunosuppression medications. Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)/donor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB) echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing. This work will form the basis for a non-invasive, genomic blood test that can be used to monitor patients after heart transplant to mitigate complications of over-immunosuppression, such as infection, without increasing the risks of under-immunosuppression, such as rejection.
Eligibility criteria
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
Study design
Enrollment target: 250 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-10-28
Estimated completion: 2032-01-01
Last updated: 2026-03-25
Primary outcomes
  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients (up to 3 years post - transplant)
  • Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients (up to 3 years post - transplant)
Sponsor
Inova Health Care Services · other
With: National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactPalak Shah, MD · contact · palak.shah@inova.org · (703) 776-8000
ContactStephanie Wolak, MPH · contact · stephanie.wolak@inova.org · 571-472-8558
InvestigatorPalak Shah, MD · principal_investigator, Inova Schar Heart and Vascular
All locations (6)
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
Stanford UniversityRecruiting
Palo Alto, California, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Vanderbilt UniversityRecruiting
Nashville, Tennessee, United States
Baylor University Medical CenterRecruiting
Dallas, Texas, United States
Inova Health SystemNot Yet Recruiting
Falls Church, Virginia, United States
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels · TrialPath