The objective of this prospective observational single center study is to investigate donor-derived cell-free DNA (ddcfDNA), peripheral blood platelet mRNA, peripheral blood extracellular vesicle mRNA, and peripheral blood leukocyte mRNA expression in recognition of clinically significant endomyocardial biopsy (EMB) proven acute rejection in human heart transplant recipients. In detail, the objective is to develop novel biomarkers and liquid biopsies for diagnosis, prognosis, and targeted molecular therapy for primary graft failure, ischemia-reperfusion injury, acute rejection, and development of late graft failure and cardiac allograft vasculopathy, and for monitoring immunosuppression after heart transplantation.
Study Type
OBSERVATIONAL
Enrollment
100
Donor-derived cell-free DNA relation to recipient-derived cell-free DNA is compared to histopathological rejection grade from the same time frame.
Helsinki University Hospital
Helsinki, Uusimaa, Finland
RECRUITINGPlasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation
To compare plasma dd-cfDNA to endomyocardial biopsy data
Time frame: 5 years
Allograft educated platelet-derived mRNA for gene expression profiling of acute rejection after heart transplantation
To compare gene expression profile of allograft-educated platelets to endomyocardial biopsy data
Time frame: 5 years
Plasma extracellular vesicle (EV) derived mRNA for gene expression profiling of acute rejection after heart transplantation
To compare gene expression profile of EV-derived mRNA to endomyocardial biopsy data
Time frame: 5 years
Plasma glycoproteins for routine surveillance of acute rejection after heart transplantation
To compare plasma glycoproteome profile to endomyocardial biopsy data
Time frame: 5 years
Plasma metabolomics changes during acute rejection after heart transplantation
Plasma metabolic changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation to investigate if there are any plasma metabolomics changes during different grades of acute rejection.
Time frame: 1 year
Plasma proteomics changes during acute rejection after heart transplantation
Plasma proteomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation to investigate if there are any plasma proteomics changes during different grades of acute rejection during the first year.
Time frame: 1 year
Peripheral blood mononuclear cell mRNA expression for gene expression profiling of acute rejection after heart transplantation
To compare gene expression profile of peripheral blood mononuclear cells to endomyocardial biopsy data
Time frame: 1 year
Plasma metabolomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Plasma metabolomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and their relationship to the development of cardiac allograft vasculopathy in coronary angiogram will be investigated at 1, 3, and 5 years.
Time frame: 5 years
Plasma metabolomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Plasma metabolomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and their relationship to patient survival will be investigated at 1, 3, and 5 years.
Time frame: 5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Plasma proteomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and their relationship to the development of cardiac allograft vasculopathy in coronary angiogram will be investigated at 1, 3, and 5 years.
Time frame: 5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Plasma proteomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and and their relationship to patient survival will be investigated at 1, 3, and 5 years.
Time frame: 5 years
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