Clinical trial NCT06064123: Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
Official title: Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Transplant Rejection
Keywords: Donor-derived Cell-Free DNA
Platelet
Endomyocardial biopsy
Liquid biopsy
Transcriptome
Proteomics
Metabolomics
Glycoproteins
Surveillance
Extracellular Vesicles
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consist of heart transplant recipients transplanted at the Helsinki University Hospital, Helsinki, Finland.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patient age \> 18 years
* heart transplant recipient
* has signed informed consent

Exclusion Criteria:

* foreign residency
* no signed informed consent collected

Primary outcomes:
measure: Plasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation
timeFrame: 5 years
measure: Allograft educated platelet-derived mRNA for gene expression profiling of acute rejection after heart transplantation
timeFrame: 5 years
measure: Plasma extracellular vesicle (EV) derived mRNA for gene expression profiling of acute rejection after heart transplantation
timeFrame: 5 years
measure: Plasma glycoproteins for routine surveillance of acute rejection after heart transplantation
timeFrame: 5 years
Secondary outcomes:
measure: Plasma metabolomics changes during acute rejection after heart transplantation
timeFrame: 1 year
measure: Plasma proteomics changes during acute rejection after heart transplantation
timeFrame: 1 year
measure: Peripheral blood mononuclear cell mRNA expression for gene expression profiling of acute rejection after heart transplantation
timeFrame: 1 year
measure: Plasma metabolomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
timeFrame: 5 years
measure: Plasma metabolomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
timeFrame: 5 years
measure: Plasma proteomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
timeFrame: 5 years
measure: Plasma proteomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Karl B Lemström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: