Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414603
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-02
Brief Title:
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
Sponsor:
Natera Inc
Organization:
Natera Inc
Study Overview
Official Title:
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy ACES-EMB
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ACES-EMB
Brief Summary:
This is an open label Comparative Effectiveness Research CER study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 21 ratio Prospera to EMB at each site
Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation All subjects will follow the centers standard of care surveillance schedule from transplant through 4 weeks post-transplantation EMB during this phase is expected to occur roughly weekly or bi-weekly
Study group assignment will take place at randomization Subjects will be randomized 30 days 10 days post-transplant to Prospera surveillance versus EMB surveillance in a 21 ratio Rejection surveillance Prospera Group and EMB Group will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance
Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation All subjects will follow the centers standard of care surveillance schedule from transplant through 4 weeks post-transplantation EMB during this phase is expected to occur roughly weekly or bi-weekly
Study group assignment will take place at randomization Subjects will be randomized 30 days 10 days post-transplant to Prospera surveillance versus EMB surveillance in a 21 ratio Rejection surveillance Prospera Group and EMB Group will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance
Detailed Description:
All subjects will undergo standard of care assessments for rejection monitoring in addition to Prospera testing andor EMB in accordance with each sites clinical care protocols and at the discretion of the treating clinician Quality of life questionnaires will be completed at week 4 month 6 and month 12 post-transplant
Study Group Prospera dd-cfDNA Surveillance Group Subjects are required to undergo Prospera testing at times corresponding to the institutions graft surveillance schedule Prospera test results will be provided to the clinical team Prospera cfDNA level 015 will be interpreted as low risk for acute rejection AR Prospera cfDNA 015 will be interpreted as increased risk for AR and may be followed by EMB to rule out AR at the discretion of the treating clinicians All other standard of care modalities for assessing AR can be used at the discretion of the treating clinicians at any time throughout the study As per standard of care in subjects with clinical signs or symptoms of rejection a for cause EMB can be done per the clinical teams discretion at any time during the study
Control Group EMB Surveillance Group Subjects will undergo surveillance EMB per the institutions standard clinical care Biopsy interpretation will be per the institutional pathologist using international guidelines for grading of acute cellular or antibody-mediated rejection Subjects will also have Prospera testing performed at the time of surveillance EMB for the purpose of measuring concordance between dd-cfDNA surveillance testing and surveillance EMB Prospera results will not be returned to investigators for subjects in the EMB surveillance group
Subjects in both the Prospera and EMB Surveillance Groups will have Prospera blood draws performed at the time of any for cause EMB Results of Prospera testing performed in conjunction with for cause EMB will not be returned to investigators or subjects
Blood samples for exploratory mechanistic endpoints miRNA will be obtained at the time of each Prospera or EMB surveillance visit and at the time of any for cause EMB
The study period will be during the first 12 months post-transplant
Study Group Prospera dd-cfDNA Surveillance Group Subjects are required to undergo Prospera testing at times corresponding to the institutions graft surveillance schedule Prospera test results will be provided to the clinical team Prospera cfDNA level 015 will be interpreted as low risk for acute rejection AR Prospera cfDNA 015 will be interpreted as increased risk for AR and may be followed by EMB to rule out AR at the discretion of the treating clinicians All other standard of care modalities for assessing AR can be used at the discretion of the treating clinicians at any time throughout the study As per standard of care in subjects with clinical signs or symptoms of rejection a for cause EMB can be done per the clinical teams discretion at any time during the study
Control Group EMB Surveillance Group Subjects will undergo surveillance EMB per the institutions standard clinical care Biopsy interpretation will be per the institutional pathologist using international guidelines for grading of acute cellular or antibody-mediated rejection Subjects will also have Prospera testing performed at the time of surveillance EMB for the purpose of measuring concordance between dd-cfDNA surveillance testing and surveillance EMB Prospera results will not be returned to investigators for subjects in the EMB surveillance group
Subjects in both the Prospera and EMB Surveillance Groups will have Prospera blood draws performed at the time of any for cause EMB Results of Prospera testing performed in conjunction with for cause EMB will not be returned to investigators or subjects
Blood samples for exploratory mechanistic endpoints miRNA will be obtained at the time of each Prospera or EMB surveillance visit and at the time of any for cause EMB
The study period will be during the first 12 months post-transplant
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?:
None