Nationwide Swedish program testing donor-derived cell-free DNA to monitor rejection after heart transplant
A National Swedish Study Evaluating Donor-derived Cell-free DNA as a Diagnostic Biomarker in Heart Transplantation (SweD-HTx)
Karolinska Institutet · NCT07531784
This project tests whether a blood test measuring donor-derived cell-free DNA can help monitor rejection in adults who have had a heart transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07531784 on ClinicalTrials.gov |
What this trial studies
This observational multicenter cohort will enroll adult heart transplant recipients at three Swedish centers (Lund, Gothenburg, Stockholm) and collect blood for donor-derived cell-free DNA (dd-cfDNA) alongside routine endomyocardial biopsies. dd-cfDNA will be quantified using next-generation sequencing to determine donor fraction and compared with biopsy results and clinical events. The goal is to establish a nationwide protocol for dd-cfDNA-based rejection surveillance and to improve understanding of rejection mechanisms and immune activation. Standard outpatient follow-up at the participating transplant clinics will be used for longitudinal sample collection and clinical correlation.
Who should consider this trial
Good fit: Adults (age ≥18) who undergo orthotopic heart transplantation and are followed at one of the participating Swedish transplant centers are ideal candidates.
Not a fit: Patients who are pregnant, have undergone multi-organ transplantation, or have a history of other solid organ or hematopoietic stem cell transplantation (and children under 18) are not eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could allow earlier, less invasive detection of rejection and reduce the need for frequent biopsies.
How similar studies have performed: Similar dd-cfDNA approaches have shown promise in U.S. heart transplant programs and in other solid-organ transplants, though European data remain more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years) who undergo orthotopic HTx. Exclusion Criteria: * Pregnancy, * Multi-organ transplantation * Solid organ * Hematopoietic stem cell transplantation.
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
Study contacts
- Principal investigator: Michael Melin, MD, PhD — Region Stockholm
- Study coordinator: Ida Haugen-Löfman, MD, PhD
- Email: ida.haugen-lofman@regionstockholm.se
- Phone: 046708744502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Transplantation, Heart Transplant Rejection, heart transplantation rejection surveillence