A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart Transplantation
NCT ID: NCT03477383
Last Updated: 2022-05-02
Study Results
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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COMPLETED
134 participants
OBSERVATIONAL
2016-03-01
2021-12-31
Brief Summary
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Detailed Description
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Secondary objectives are description of patient outcomes with respect to organ function, quality of life and adverse events.
Secondary objectives are the calculation of the costs related to the transplantation process as well as to the follow-up with EMB. A simulation will be done with respect to possible savings achieved if the new biomarker could be implemented.
The study consists of two cohorts: all adult recipients of heart transplantation at Sahlgrenska University Hospital (one of two center conducting heart transplantation in Sweden): regional study. The other cohort consists of all children undergoing heart transplantation in Sweden:national study. Patients will undergo transplantation at Sahlgrenska University Hospital in Gothenburg as well as at Skåne University Hospital in Lund. Follow-up with blood samples and EMB of these patients will be in Gothenburg, Lund and at Karolinska University Hospital in Stockholm.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult patients
Adult patients (18 years or older) undergoing heart transplantation
donor-derived cell-free DNA (dd-cfDNA)
Measurement of dd-cfDNA and comparison against grade of rejection as measured by endomyocardial biopsy, taken simultaneously
Pediatric patients
Pediatric patients (0-17 years) undergoing heart transplantation
donor-derived cell-free DNA (dd-cfDNA)
Measurement of dd-cfDNA and comparison against grade of rejection as measured by endomyocardial biopsy, taken simultaneously
Interventions
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donor-derived cell-free DNA (dd-cfDNA)
Measurement of dd-cfDNA and comparison against grade of rejection as measured by endomyocardial biopsy, taken simultaneously
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent
Exclusion Criteria
ALL
No
Sponsors
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Lund University Hospital
OTHER
Karolinska University Hospital
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Jan Sunnegårdh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Heart Center, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital
Locations
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Transplantation Center, Sahlgrenska University Hospital
Gothenburg, , Sweden
Pediatric Heart Center, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital
Gothenburg, , Sweden
Pediatric Heart Center, Skåne University Hospital
Lund, , Sweden
Pediatric Heart Center, Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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Bohmer J, Wasslavik C, Andersson D, Stahlberg A, Jonsson M, Wahlander H, Karason K, Sunnegardh J, Nilsson S, Asp J, Dellgren G, Ricksten A. Absolute Quantification of Donor-Derived Cell-Free DNA in Pediatric and Adult Patients After Heart Transplantation: A Prospective Study. Transpl Int. 2023 Oct 30;36:11260. doi: 10.3389/ti.2023.11260. eCollection 2023.
Other Identifiers
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014-16
Identifier Type: OTHER
Identifier Source: secondary_id
ver 1.0
Identifier Type: -
Identifier Source: org_study_id
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