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A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart Transplantation

NCT03477383 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 134

Last updated 2022-05-02

No results posted yet for this study

Summary

This study is a prospective, observational multi-center cohort study. The study will consist of patients undergoing heart transplantation. The main purpose is to test a new biomarker for rejection against the gold-standard, the endomyocardial biopsy (EMB). 80 patients will be included, both children and adults.

Conditions

  • Heart Transplant Rejection

Interventions

DIAGNOSTIC_TEST

donor-derived cell-free DNA (dd-cfDNA)

Measurement of dd-cfDNA and comparison against grade of rejection as measured by endomyocardial biopsy, taken simultaneously

Sponsors & Collaborators

  • Lund University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Jan Sunnegårdh, MD, PhD · Pediatric Heart Center, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03477383 on ClinicalTrials.gov