Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging (DRAGON)

Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Graft
• Intervention / Treatment: Procedure: cardiac MRI; Drug: gadobenic acid intravenous injection 0.2 ml/kg

Detailed Description

Acute heart allograft rejection is a common complication after orthotopic heart transplantation. It can lead to multiple cardiac injuries and sometimes to patient's death. Currently, acute heart graft rejection screening is based on invasive strategies. Gold standard is represented by endomyocardial biopsies which provide side effects risk, rare but potentially fatal for the recipient. Cardiac MRI is an imaging tool recently used in cardiology. It is a non-invasive without any X-Ray exposition method well adapted to assess cardiac function and cardiac muscle composition. Cardiac MRI is probably a great tool to help the screening of acute heart allograft rejection, by detecting changes in myocardium structure. MRI validation as a screening tool for heart allograft rejection detection could help to reduce endomyocardial biopsies realised after orthotopic heart transplantation.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Orthotopic heart transplantation patients
• Endomyocardial biopsies < 72h
• Estimated glomerular filtration ratio >30ml/min (calculated by Cockcroft formula for patients age < 65 yo or MDRD for patients age >65 ans)
• Patients affiliated to French national health insurance
• For pre-menopausal female patients, negative pregnancy test
• Patient's consent form signature
• Patient with correct French writing and speaking comprehension

Exclusion Criteria:

• Endomyocardial biopsies showing acute cellular rejection grade 1R or antibodies mediated rejection pAMR1
• Patient in need of renal dialysis
• Past history of allergic reaction or side effects after gadolinium infusion
• Hemodynamical instability
• MRI contra-indication (claustrophobia, ocular metallic objects, non MRI compatible cardiac device, neurological non RMI compatible device, osteosynthesis prosthesis older than 1980)
• Pregnant or breast feeding woman
• Patient participating to another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart graft rejection; Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time	Procedure: cardiac MRI; Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time; Drug: gadobenic acid intravenous injection 0.2 ml/kg; gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment
Active Comparator: No rejection; Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time	Procedure: cardiac MRI; Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time; Drug: gadobenic acid intravenous injection 0.2 ml/kg; gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Extracellular volume as measured by Cardiac MRI	Day 1
T1 as measured by Cardiac MRI	Day 1
T2 as measured by Cardiac MRI	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Arnaud GAY, MD, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): May 26, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2013/153/HP