Personalizing adult heart transplant immunosuppression using blood microRNA levels

OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

This project will try to use blood microRNA patterns to monitor immune status in adults after heart transplant and predict who will develop infection or rejection.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Inova Health Care Services (Academic / other)
• Locations: 7 sites (Los Angeles, California and 6 other locations)
• Trial ID: NCT06939751 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, observational cohort will enroll about 250 adults around one month after orthotopic heart transplant and follow them for 36 months. Blood samples will be collected at scheduled post-transplant intervals and whenever clinical events like treated rejection or infection occur to measure circulating microRNA expression. Researchers will compare microRNA patterns with immunosuppressive drug use, HLA/DSA testing, endomyocardial biopsy, dd-cfDNA, echocardiography, and clinical outcomes. The aim is to develop a non-invasive microRNA biomarker panel that reflects net immune state and predicts risk of infection and rejection.

Who should consider this trial

Good fit: Adults aged 18 or older who received a single-organ orthotopic heart transplant within the prior month (±2 weeks) and can return to the transplant center for follow-up are ideal candidates.

Not a fit: Patients with multi-organ transplants, ongoing mechanical circulatory support or hemodynamic instability, current dialysis, active infection, or active treated rejection are unlikely to be eligible or to benefit from this approach.

Why it matters

Potential benefit: If successful, this could provide a non-invasive blood test to help tailor immunosuppression, lowering infection risk without increasing rejection.

How similar studies have performed: Related genomic tools like gene-expression profiling and donor-derived cell-free DNA have shown promise for transplant monitoring, but microRNA-based panels remain largely investigational with limited independent validation.

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

Where this trial is running

Los Angeles, California and 6 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• Stanford University — Palo Alto, California, United States (Recruiting)
• Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
• Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
• Baylor University Medical Center — Dallas, Texas, United States (Recruiting)
• Inova Health System — Falls Church, Virginia, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Palak Shah, MD — Inova Schar Heart and Vascular
• Study coordinator: Palak Shah, MD

Conditions Cardiac Failure; Graft Rejection