Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation

Heart Transplant Rejection Clinical Trial

— EMBIO  

Official title:

Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064123
• Other study ID #: HUS/3654/2017
• Status: Recruiting
• Start date: January 22, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Helsinki University Central Hospital
• Contact: Karl B Lemstrom, MD, PhD
• Phone: +358504272281
• Email: Karl.Lemstrom[@]Hus.Fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• foreign residency
• no signed informed consent collected

Related Conditions & MeSH terms

• Heart Transplant Rejection

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma 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	5 years
Primary	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	5 years
Primary	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	5 years
Primary	Plasma glycoproteins for routine surveillance of acute rejection after heart transplantation	To compare plasma glycoproteome profile to endomyocardial biopsy data	5 years
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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	1 year
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years