Not Yet RecruitingNot Applicable

Quantification of Mitral Regurgitation Using 4D MRI Flow : Comparison With 2D MRI Flow and Echocardiography Using the Evolution of Left Ventricular Remodeling as a Reference

France160 participantsStarted 2025-10-01

Plain-language summary

The goal of this study is to evaluate whether 4D MRI provides a better assessment of mitral regurgitation quantification and associated ventricular remodeling than standard imaging techniques: echocardiography and 2D MRI, in patients suffuring from mitral regurgitation. 4D MRI demonstrated its superiority to 2D MRI in some other valve diseases but remains not widely used, due to a lack of evidence. The main question our study aims to answer is: • Is mitral regurgitant volume measured on 4D MRI more strongly related to remodeling progression (after correction of regurgitation or not) than regurgitant volume measured on 2D MRI and echocardiography? Participants will undergo 4D MRI, 2D MRI and echocardiography twice at six-month intervals.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion Criteria: Subjects * from 18 to 85 years old * having signed a consent form to participate in the study * suffering from mild, moderate or severe mitral regurgitation based on an ultrasound graduation * able to undergo echocardiography and IRM within 7 days after recruitment and then at 6 months Exclusion Criteria: Subjects * suffering from aortic regurgitation or stenosis or mitral stenosis associated with more than moderate MR, intracardiac shunting or hypertrophic cardiomyopathy * suffering from secondary MR * having a contraindication to gadolinium-based contrast agent * having a pacemaker, defibrillator or any other contraindication to MRI * suffering from renal disease with an eGFR CKD-EPI \< 30 ml/min * pregnant or breastfeeding * under legal protection Enrolled subjects: * with an incomplete or suboptimal ultrasound or MRI examination * who have not attended to the 6-month follow-up visit * with an intercurrent medical event will be excluded.

What they're measuring

Absolute change in left ventricle end-diastolic volume

Timeframe: Baseline, 6 months

Mitral regurgitant volume

Timeframe: Baseline

Trial details

NCT IDNCT07066904

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-30

Contact for this trial

Maxime Brussieux

+33 maxime.brussieux@aphp.fr