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

October 2, 2023 updated by: Karl Lemstrom, Helsinki University Central Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Recruiting
        • Helsinki University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study population consist of heart transplant recipients transplanted at the Helsinki University Hospital, Helsinki, Finland.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • foreign residency
  • no signed informed consent collected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac transplant recipients
The group consist of all recruited cardiac transplant recipients operated in Helsinki University Hospital
Diagnostic test: Cell-free DNA
Donor-derived cell-free DNA relation to recipient-derived cell-free DNA is compared to histopathological rejection grade from the same time frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation
Time Frame: 5 years
To compare plasma dd-cfDNA to endomyocardial biopsy data
5 years
Allograft educated platelet-derived mRNA for gene expression profiling of acute rejection after heart transplantation
Time Frame: 5 years
To compare gene expression profile of allograft-educated platelets to endomyocardial biopsy data
5 years
Plasma extracellular vesicle (EV) derived mRNA for gene expression profiling of acute rejection after heart transplantation
Time Frame: 5 years
To compare gene expression profile of EV-derived mRNA to endomyocardial biopsy data
5 years
Plasma glycoproteins for routine surveillance of acute rejection after heart transplantation
Time Frame: 5 years
To compare plasma glycoproteome profile to endomyocardial biopsy data
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma metabolomics changes during acute rejection after heart transplantation
Time Frame: 1 year
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.
1 year
Plasma proteomics changes during acute rejection after heart transplantation
Time Frame: 1 year
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.
1 year
Peripheral blood mononuclear cell mRNA expression for gene expression profiling of acute rejection after heart transplantation
Time Frame: 1 year
To compare gene expression profile of peripheral blood mononuclear cells to endomyocardial biopsy data
1 year
Plasma metabolomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Time Frame: 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 the development of cardiac allograft vasculopathy in coronary angiogram will be investigated at 1, 3, and 5 years.
5 years
Plasma metabolomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Time Frame: 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.
5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Time Frame: 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 their relationship to the development of cardiac allograft vasculopathy in coronary angiogram will be investigated at 1, 3, and 5 years.
5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Karl B Lemström, MD, PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUS/3654/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe