Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation (EMBIO)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Heart Transplant Rejection

Treatments: Diagnostic Test: Cell-free DNA

Study type: Observational

Funder types: Other

Identifiers

NCT06064123

HUS/3654/2017

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• foreign residency
• no signed informed consent collected

Trial design

100 participants in 1 patient group

Cardiac transplant recipients

Description:

The group consist of all recruited cardiac transplant recipients operated in Helsinki University Hospital

Treatment:

Diagnostic Test: Cell-free DNA