FreeDNA-CAR is a prospective, observational multicenter study, that will include a total of 200 adult heart transplant (HT) patients from 14 centers in Spain. Our main objective is to test donor-derived Cell-Free DNA (dd-cfDNA) against endomyocardial biopsy (EMB) for the diagnosis of acute cellular rejection.
All patients will be enrolled immediately after HT, and will undergo undergo routine surveillance EMB at 15 days, 1 month, 2, 3, 4, 6 and 12 months after HT. Simultaneously with each EMB, dd-cfDNA will be measured in plasma.
Study Type
OBSERVATIONAL
Enrollment
200
Measurement of dd-cfDNA and comparison against grade of rejection as determined by endomyocardial biopsy, taken simultaneously
University Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
RECRUITINGClinica Universitaria de Navarra
Pamplona, Navarre, Spain
RECRUITINGAssociation between dd-cfDNA levels and the presence of acute cellular rejection
Association between dd-cfDNA levels above a certain cut-point and the presence of treatable acute cellular rejection as determined by endomyocardial biopsy (graded by International Society of Heart and Lung Transplantation 2010 classification, grade \> 1R).
Time frame: 1 year
Area under curve for dd-cfDNA
To define a cutt-off point of dd-cfDNA level with a high negative predictive value that could obviate the need to perform surveillance endomyocardial biopsies
Time frame: 1 year
Correlation between dd-cfDNA and antibody mediated rejection (AMR)
Correlation between dd-cfDNA and antibody mediated rejection (AMR)
Time frame: 1 year
Association between dd-cfDNA and immunosuppressive (IS) treatment
Subanalysis of association between dd-cfDNA and rejection stratified by IS regimen (type and dose of drug).
Time frame: 1 year
Association between dd-cfDNA (%) and left ventricular ejection fraction
Association between dd-cfDNA and left ventricular ejection fraction (LVEF). All echocardiograms will be performed on the same day of EMB.
Time frame: 1 year
Determine the biomarker's kinetics at 15 days post-transplant
Determine dd-cfDNA levels at 15 days post-transplant in absence of rejection
Time frame: 15 days
Association between dd-cfDNA levels and cytomegalovirus (CMV) infection
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Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
RECRUITINGHospital Universitario A Coruña
A Coruña, Spain
RECRUITINGHospital Bellvitge
Barcelona, Spain
RECRUITINGHospital Clinic de Barcelona
Barcelona, Spain
RECRUITINGHospital Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGHospital 12 octubre
Madrid, Spain
RECRUITINGHospital Universitario Gregorio Marañón
Madrid, Spain
RECRUITINGHospital Virgen de la Arrixaca
Murcia, Spain
RECRUITING...and 2 more locations
Association between dd-cfDNA levels and CMV infection as determined by CMV polymerase chain reaction (number of copies per ml)
Time frame: 1 year
Determine a cut-off point of dd-cfDNA that allows to differentiate between acute cellular rejection (ACR) and antibody mediated rejection (AMR)
Determine a cut-off point of dd-cfDNA that allows to differentiate between acute cellular rejection (ACR) and antibody mediated rejection (AMR)
Time frame: 1 year