NCT07531784 A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplantation
| NCT ID | NCT07531784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Heart Transplantation |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The SweD-HTx-study is an observational, multicenter cohort study including adult HTx recipients from Skåne University Hospital (Lund), Sahlgrenska University Hospital (Gothenburg), and Karolinska University Hospital (Stockholm). The aim of the study is to establish a robust, nationwide protocol for dd-cfDNA-based rejection monitoring in Swedish HTx recipients and to enhance our understanding of rejection mechanisms and immune activation. All participants undergo endomyocardial biopsies as part of routine post-transplant surveillance. Heart transplantations are performed at Skåne University Hospital or Sahlgrenska University Hospital, with post-transplant follow-up conducted at the outpatient transplant clinics at the participating centers. Eligible participants are adults (≥18 years) who undergo orthotopic HTx. Exclusion criteria include pregnancy, multi-organ transplantation, or a history of other solid organ or hematopoietic stem cell transplantation. Peripheral blood samples are collected according to standardized operating procedures and transported at ambient temperature to the immunology laboratory for processing. A subset of samples is immediately cryopreserved upon collection. Clinical and demographic data are extracted from the electronic medical record (EMR) using standardized data collection forms. The main outcome is the correlation between analyzed dd-cfDNA fraction levels and biopsy-proven rejection, defined by International Society of Heart and Lung Transplantation (ISHLT)'s histopathological criteria. The longitudinal changes in dd-cfDNA fraction and DSA will be analyzed as well as the association between DSA and dd-cfDNA fraction.
Eligibility Criteria
Inclusion Criteria: * Adults (≥18 years) who undergo orthotopic HTx. Exclusion Criteria: * Pregnancy, * Multi-organ transplantation * Solid organ * Hematopoietic stem cell transplantation.
Contact & Investigator
Michael Melin, MD, PhD
PRINCIPAL INVESTIGATOR
Region Stockholm
Frequently Asked Questions
Who can join the NCT07531784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07531784 currently recruiting?
Yes, NCT07531784 is actively recruiting participants. Contact the research team at ida.haugen-lofman@regionstockholm.se for enrollment information.
Where is the NCT07531784 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT07531784 clinical trial?
NCT07531784 is sponsored by Karolinska Institutet. The principal investigator is Michael Melin, MD, PhD at Region Stockholm. The trial plans to enroll 120 participants.