NCT03477383

Brief Summary

This study is a prospective, observational multi-center cohort study. The study will consist of patients undergoing heart transplantation. The main purpose is to test a new biomarker for rejection against the gold-standard, the endomyocardial biopsy (EMB). 80 patients will be included, both children and adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 2, 2022

Status Verified

October 1, 2021

Enrollment Period

5.8 years

First QC Date

March 15, 2018

Last Update Submit

April 29, 2022

Conditions

Heart Transplant Rejection

Keywords

diagnosiseconomicscell-free DNAdigital droplet PCRheart failure

Outcome Measures

Primary Outcomes (1)

  • Comparison of donor-derived cell-free DNA and endomyocardial biopsy with respect to rejection

    Measurement of both fraction of donor-derived cell-free DNA of all cell-free DNA (derived from recipient and donor) as well as the absolute number of copies per ml plasma derived from the donor. Comparison is made with simultaneously obtained endomyocardial biopsies that are graded with respect to rejection, according to the official guidelines provided by the International Society of Heart and Lung Transplantation.

    3 years

Secondary Outcomes (26)

  • Cost analysis 1

    5 years

  • Rejection

    5 years

  • Graft-vasculopathy

    5 years

  • Overweight

    5 years

  • Quality of life

    5 years

  • +21 more secondary outcomes

Study Arms (2)

Adult patients

Adult patients (18 years or older) undergoing heart transplantation

Diagnostic Test: donor-derived cell-free DNA (dd-cfDNA)

Pediatric patients

Pediatric patients (0-17 years) undergoing heart transplantation

Diagnostic Test: donor-derived cell-free DNA (dd-cfDNA)

Interventions

donor-derived cell-free DNA (dd-cfDNA)DIAGNOSTIC_TEST

Measurement of dd-cfDNA and comparison against grade of rejection as measured by endomyocardial biopsy, taken simultaneously

Adult patientsPediatric patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients on waiting list for heart transplantion at the participating centers

You may qualify if:

  • Patient on waiting list for heart transplantation
  • Signed informed consent

You may not qualify if:

  • \. Follow-up outside Sweden

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Transplantation Center, Sahlgrenska University Hospital

Gothenburg, 41234, Sweden

Location

Pediatric Heart Center, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital

Gothenburg, 41685, Sweden

Location

Pediatric Heart Center, Skåne University Hospital

Lund, 22241, Sweden

Location

Pediatric Heart Center, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Bohmer J, Wasslavik C, Andersson D, Stahlberg A, Jonsson M, Wahlander H, Karason K, Sunnegardh J, Nilsson S, Asp J, Dellgren G, Ricksten A. Absolute Quantification of Donor-Derived Cell-Free DNA in Pediatric and Adult Patients After Heart Transplantation: A Prospective Study. Transpl Int. 2023 Oct 30;36:11260. doi: 10.3389/ti.2023.11260. eCollection 2023.

    PMID: 37965628DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma (10ml)

MeSH Terms

Conditions

DiseaseHeart Failure

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Jan Sunnegårdh, MD, PhD

    Pediatric Heart Center, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 26, 2018

Study Start

March 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 2, 2022

Record last verified: 2021-10

Locations

SE(4)