NCT02261870: DRAGET

Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2

Completed NA Last updated 12 May 2020

What this trial tests

NA trial testing MRI T2 quantification in Acute Graft Rejection in 116 participants. Completed in 27 February 2020.

Timeline

18 February 2015

Primary endpoint
27 February 2020

27 February 2020

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	116
Start date	18 February 2015
Primary completion	27 February 2020
Estimated completion	27 February 2020
Sites	10 locations across France

Drugs / interventions tested

• MRI T2 quantification

Conditions studied

• Acute Graft Rejection — all drugs for Acute Graft Rejection →
• Heart Transplantation — all drugs for Heart Transplantation →

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Acute Graft Rejection or Heart Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification.

Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Design of the DRAGET Study: a multicentre controlled diagnostic study to assess the detection of acute rejection in patients with heart transplant by means of T2 quantification with MRI in comparison to myocardial biopsies.
   Bonnemains L, Cherifi A, Girerd N, Odille F, et al · · 2015 · cited 12× · PMID 26515686 · DOI 10.1136/bmjopen-2015-008963