Nationwide Swedish program testing donor-derived cell-free DNA to monitor rejection after heart transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (≥18 years) who undergo orthotopic HTx.

Exclusion Criteria:

* Pregnancy,
* Multi-organ transplantation
* Solid organ
* Hematopoietic stem cell transplantation.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.