OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels (Optimal)

Not yet recruiting

• Conditions: Cardiac Failure; Graft Rejection

• Registration Number: NCT06939751
• Lead Sponsor: Inova Health Care Services

Brief Summary

This study aims to develop and refine a miR biomarker panel that can be used to phenotype net immune state after heart transplantation.

Detailed Description

The study objectives will be accomplished in a prospective, longitudinal, multicenter, multiracial, multiethnic cohort study that includes adult heart transplant patients from geographically and socioeconomically diverse regions of the U.S. Patients will be screened for eligibility and enrolled \~1 month (± 2 weeks) after transplant.

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

2. when a clinical event of interest occurs, including rejection or infection.

Research samples will be collected and used to evaluate microRNA expression as well as other biomarkers related to heart transplantation and immunosuppressive 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Study Start: 2025-06-03
• Primary Completion: 2031-01-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients	up to 3 years post - transplant	A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of infection in heart transplant recipients. Infections are defined as any bacterial, viral, fungal, or opportunistic infection leading to: 1) hospitalization, 2) prescription of antimicrobial therapy, or 3) reduction in immunosuppression
Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients	up to 3 years post - transplant	A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of rejection in heart transplant recipients. Rejection is defined as treated rejection based on 1) endomyocardial biopsy (EMB) pathology, 2) unexplained graft dysfunction, or 3) molecular testing; leading to treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg).; EMB Pathology: Acute Cellular Rejection (ACR) Grade ≥ 2R and/or Antibody-mediated Rejection (AMR) Grade ≥ pAMR1, per International Society for Heart and Lung Transplantation (ISHLT) grading systems.; Graft Dysfunction: Left Ventricular Ejection Fraction (LVEF) decline ≥ 10% from baseline and \< 50% absolute LVEF by echocardiography.; Molecular Testing: Presence of 2 of the following 3 criteria-presence of HLA-DSA, elevated donor-derived cell-free DNA (dd-cfDNA), or gene expression results from blood or EMB testing.

Trial Locations

Locations (1)

Inova Health System; 🇺🇸 Falls Church, Virginia, United States