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

University Hospital, Rouen

Status: Withdrawn

Conditions: Cardiac Graft

Treatments: Drug: gadobenic acid intravenous injection 0.2 ml/kg; Procedure: cardiac MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02400840

2013/153/HP

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Heart graft rejection

Experimental group

Description:

Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time

Treatment:

Drug: gadobenic acid intravenous injection 0.2 ml/kg

Procedure: cardiac MRI

No rejection

Active Comparator group

Description:

Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time

Treatment:

Drug: gadobenic acid intravenous injection 0.2 ml/kg

Procedure: cardiac MRI