Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-01 @ 1:06 PM
Study NCT ID:
NCT06939751
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Sponsor:
Inova Health Care Services
Organization:
Study Overview
Official Title:
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMAL
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HL173248-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |