Clinical Trial

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

Study acronym: FLAME
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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.
Trial Details
NCT Number NCT07066904
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Ministry of Health, France, GIRCI IDF
Conditions Mitral Regurgitation (MR)
Enrollment 160 participants
Start Date 2025-10-01
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-15