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

NCT ID: NCT06064123

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-22

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac transplant recipients

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

Cell-free DNA

Intervention Type DIAGNOSTIC_TEST

Donor-derived cell-free DNA relation to recipient-derived cell-free DNA is compared to histopathological rejection grade from the same time frame.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* foreign residency
* no signed informed consent collected
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karl Lemstrom

Professor of Cardiothoracic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl B Lemström, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Hospital

Helsinki, Uusimaa, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Karl B Lemstrom, MD, PhD

Role: CONTACT

+358504272281

Facility Contacts

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Karl B Lemstrom, MD, PhD

Role: primary

+358504272281

Other Identifiers

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HUS/3654/2017

Identifier Type: -

Identifier Source: org_study_id

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