A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplantation

NCT07531784 | Recruiting

• 1 other identifier: 2024-03357-01, 2025-04085-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation; Heart Transplant Rejection

Keywords

heart transplantation rejection surveillence

Outcome Measures

Primary Outcomes (1)

• Correlation between dd-cfDNA fraction levels and biopsy-proven rejection

  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 longitudinell changes in dd-cfDNA fraction and DSA will be analyzed as well as the the association between DSA and dd-cfDNA fraction.

  through study completion, an average of 1 year

Other Outcomes (1)

• Incidence of graft dysfunction and cardiac allograft vasculopathy (CAV) + association between ddcf-DNA and biomarkers

  From enrolment up to five years

Study Arms (1)

Heart transplant patients

Diagnostic Test: dd-cfDNA

Interventions

dd-cfDNA DIAGNOSTIC_TEST

Analysis of correlation between analyzed dd-cfDNA fraction levels and biopsy-proven rejection,

Heart transplant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include adult HTx recipients from Skåne University Hospital (Lund), Sahlgrenska University Hospital (Gothenburg), and Karolinska University Hospital (Stockholm). 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Heart biopsies. Blood samples.

Study Officials

• Michael Melin, MD, PhD

  Region Stockholm

  PRINCIPAL INVESTIGATOR

• Michael Melin

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida Haugen-Löfman, MD, PhD

CONTACT

046708744502; ida.haugen-lofman@regionstockholm.se

Melin

CONTACT

046723888636; michael.melin@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 15, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2036
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)