Actively Recruiting
A National Swedish Study Evaluating Donor-derived Cell-free DNA as a Diagnostic Biomarker in Heart Transplantation (SweD-HTx)
Led by Karolinska Institutet · Updated on 2026-04-15
120
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an observational, multicenter cohort study called the SweD-HTx study, involving adult heart transplant recipients from three Swedish university hospitals. The study aims to develop a nationwide protocol for monitoring transplant rejection using donor-derived cell-free DNA (dd-cfDNA) and to better understand rejection mechanisms and immune activation. This study focuses on adults who have undergone orthotopic heart transplantation, with exclusion of those who are pregnant or have had multiple organ or stem cell transplants. Participants receive routine post-transplant care including endomyocardial biopsies at scheduled intervals. Blood samples are collected alongside these biopsies for dd-cfDNA and donor-specific antibody (DSA) analysis, using next-generation sequencing and standardized laboratory procedures. The study will analyze the relationship between dd-cfDNA levels and biopsy-confirmed rejection, following international histopathological criteria. The collection of clinical and demographic data from electronic medical records supports comprehensive analysis. Participants are monitored over several years with blood sampling coordinated with routine biopsies during the first two years post-transplant and annual data collection up to five years. Outcomes include the correlation between dd-cfDNA fraction levels and biopsy-proven rejection, longitudinal changes in dd-cfDNA and DSA, and their association. Safety and standard care continue throughout, with data securely managed and analyzed to improve rejection monitoring methods in heart transplantation.
CONDITIONS
Brief Title
A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years) who undergo orthotopic heart transplantation.
You will not qualify if you...
- Pregnancy
- Multi-organ transplantation
- Prior solid organ transplantation
- Prior hematopoietic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 years during recruitment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility
Duration - Up to 2 years post-transplant
Participants undergo blood sample collection for donor-derived cell-free DNA (dd-cfDNA) and donor-specific antibody (DSA) analysis, coordinated with routine endomyocardial biopsies to monitor for heart transplant rejection.
Multiple visits coordinated with routine biopsies: weekly for weeks 1-4, then at months 2, 2.5, 3, 4, 5, 6, 8-9, 10-12, 16, 20, and 24
Duration - Up to 5 years post-transplant
Participants are monitored for up to five years post-transplant with annual data collection to assess graft function, rejection markers, and long-term outcomes.
Annual visits for data collection
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
Research Team
I
Ida Haugen-Löfman, MD, PhD
M
Melin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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