OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

Last updated: March 24, 2026
Sponsor: Inova Health Care Services
Overall Status: Active - Recruiting

Phase

N/A

Condition

Organ Transplant

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT06939751
INOVA-2024-372
1R01HL173248-01A1
  • Ages 18-99
  • All Genders

Study 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 Criteria

Inclusion

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

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 orvasopressor therapy)

  • Ongoing need for renal replacement therapy and/or dialysis

  • Active infection requiring either a) hospitalization b) treatment with antimicrobialtherapy or c) reduction in immunosuppression

  • Active rejection being treated with intravenous medications or plasmapheresis

Study Design

Total Participants: 250
Study Start date:
October 28, 2025
Estimated Completion Date:
January 01, 2032

Study Description

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.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Vanderbilt University

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Baylor University Medical Center

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • Inova Health System

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Inova Health System

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.