Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532890
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs OPTIMA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMA
Brief Summary:
This study aims to discover circulating microRNAs associated with drug doses and levels that can be used to characterize the overall immune state in pediatric 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 100-150 Pediatric Heart Transplant PHT patients from the United States Patients will be screened for eligibility and enrolled 1 month after PHT Study participation will last 24 months
All patients will follow the centers 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 rejection infection or major change in immunosuppression
Research samples will be collected and used to evaluate microRNA expression as well as other biomarkers related to heart transplantation and immunosuppression medications Additional data collection will include demographics medical history medications human leukocyte HLAdonor 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 centers 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 rejection infection or major change in immunosuppression
Research samples will be collected and used to evaluate microRNA expression as well as other biomarkers related to heart transplantation and immunosuppression medications Additional data collection will include demographics medical history medications human leukocyte HLAdonor 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None