Who is sponsoring NCT03477383?

NCT03477383 is sponsored by Vastra Gotaland Region.

What drugs are being tested in NCT03477383?

Interventions in NCT03477383: donor-derived cell-free DNA (dd-cfDNA).

What condition does NCT03477383 study?

NCT03477383 studies Heart Transplant Rejection.

Is NCT03477383 still recruiting?

NCT03477383 is currently completed. Last updated 2 May 2022.

Last reviewed 2022-05-02 · How we verify

NCT03477383: BIODRAFT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart Transplantation

Completed Last updated 2 May 2022

What this trial tests

trial testing donor-derived cell-free DNA (dd-cfDNA) in Heart Transplant Rejection in 134 participants. Completed in 31 December 2021.

Timeline

1 March 2016

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Vastra Gotaland Region
Status	Completed
Study type	OBSERVATIONAL
Enrollment	134
Start date	1 March 2016
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	4 locations across Sweden

Drugs / interventions tested

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

Conditions studied

Heart Transplant Rejection — all drugs for Heart Transplant Rejection →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

Eligibility, any sex, with Heart Transplant Rejection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Absolute Quantification of Donor-Derived Cell-Free DNA in Pediatric and Adult Patients After Heart Transplantation: A Prospective Study.
Böhmer J, Wasslavik C, Andersson D, Ståhlberg A, et al · · 2023 · cited 11× · PMID 37965628 · DOI 10.3389/ti.2023.11260
A two-threshold algorithm using donor-derived cell-free DNA fraction and quantity to detect acute rejection after heart transplantation.
Kim PJ, Olympios M, Sideris K, Tseliou E, et al · · 2025 · cited 9× · PMID 40334845 · DOI 10.1016/j.ajt.2025.04.021
Cell-free DNA in the surveillance of heart transplant rejection.
Sharma D, Subramaniam G, Sharma N, Sharma P. · · 2021 · cited 1× · PMID 33967413 · DOI 10.1007/s12055-020-01130-9

Verify or expand the search:

Other recruiting trials for Heart Transplant Rejection

Currently open trials in the same condition.

NCT07531784 — A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplan · recruiting
NCT05732779 — Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant R · NA · recruiting
NCT06656065 — IMR-Heart Trasplant Study · recruiting
NCT05205551 — Prospera Test Evaluation in Cardiac Transplant (ProTECT) · active not recruiting
NCT05184426 — MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT) · active not recruiting

Other Vastra Gotaland Region trials

Trials by the same sponsor.

NCT07430865 — The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation · NA · recruiting
NCT07472335 — Home-based Acute Care for Older Persons Initiated by the Emergency Medical and Ambulance Services - a Retrospective Obse · not yet recruiting
NCT07246577 — The VGR GCA Cohort: Ultrasound, Biopsy and Biomarkers - Novel Methods for Diagnosis, Monitoring and Prognosis in Giant C · recruiting
NCT07449338 — Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS) · not yet recruiting
NCT07334340 — Modified vs Standard CDED: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03477383 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vastra Gotaland Region
Last refreshed: 2 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03477383.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing