Clinical trial NCT06939751: OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels (Optimal)
Official title: OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels (Optimal)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Failure
Graft Rejection
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-04-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years of age from geographically and socioeconomically diverse regions of the U.S who have undergone orthotopic heart transplant (OHT)

Patients will be screened for eligibility and enrolled within \~ 1 month after heart transplant

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.

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

Primary outcomes:
measure: Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients
timeFrame: up to 3 years post - transplant
measure: Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients
timeFrame: up to 3 years post - transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
Study officials:
affiliation: Inova Schar Heart and Vascular
name: Palak Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah P, Bristow MR, Port JD. MicroRNAs in Heart Failure, Cardiac Transplantation, and Myocardial Recovery: Biomarkers with Therapeutic Potential. Curr Heart Fail Rep. 2017 Dec;14(6):454-464. doi: 10.1007/s11897-017-0362-8.
citation: Shah P, Agbor-Enoh S, Bagchi P, deFilippi CR, Mercado A, Diao G, Morales DJ, Shah KB, Najjar SS, Feller E, Hsu S, Rodrigo ME, Lewsey SC, Jang MK, Marboe C, Berry GJ, Khush KK, Valantine HA; GRAfT Investigators. Circulating microRNAs in cellular and antibody-mediated heart transplant rejection. J Heart Lung Transplant. 2022 Oct;41(10):1401-1413. doi: 10.1016/j.healun.2022.06.019. Epub 2022 Jun 28.