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
FLAME
4 other identifiers
interventional
160
1 country
3
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2025
CompletedFirst Posted
Study publicly available on registry
July 15, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
July 15, 2025
June 1, 2025
2.6 years
July 4, 2025
July 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Absolute change in left ventricle end-diastolic volume
The primary outcome criterion will be the analysis of the association between the absolute change in LV end-diastolic volume (LVEDV) between baseline (M0) and 6 months after (M6) and mitral regurgitant volume at M0, as calculated by the different methods or MR severity estimated using the integrative TTE approach, adjusted for residual MR.
Baseline, 6 months
Mitral regurgitant volume
The primary outcome criterion will be the analysis of the association between the absolute change in LV end-diastolic volume (LVEDV) between baseline (M0) and 6 months after (M6) and mitral regurgitant volume at M0, as calculated by the different methods or MR severity estimated using the integrative TTE approach, adjusted for residual MR.
Baseline
Secondary Outcomes (7)
Absolute change in left ventricle end-diastolic volume
Baseline, 6 months
Mitral regurgitant volume
Baseline
Absolute change in left ventricle end-diastolic volume
Baseline, 6 months
Mitral regurgitant volume
Baseline
Absolute change in left ventricle end-diastolic volume
Baseline, 6 months
- +2 more secondary outcomes
Study Arms (3)
Mild mitral regurgitation
EXPERIMENTALPatient suffuring from mild mitral regurgitation (n=30)
Moderate mitral regurgitation
EXPERIMENTALPatient suffuring from moderate mitral regurgitation (n=30)
Severe mitral regurgitation
EXPERIMENTALPatient suffuring from severe mitral regurgitation (n=100)
Interventions
Routine ultrasound examination with standardized recordings for the study, incorporating volumetric assessment techniques
A cardiac MRI will be performed on a 1.5 Tesla system, including a biventricular function study with a series of short-axis slices, three long-axis slices, a 2D phase-contrast acquisition orthogonal to the aortic root. Additionally, standard T1 mapping sequences will be acquired on three short-axis slices, 15 minutes after the injection of 0.2 mmol/kg of body weight of gadolinium, for myocardial and blood T1 measurements.
A sagittal 4D flow acquisition lasting between 6 and 10 minutes of free breathing to cover all four cardiac chambers is added to the 2D acquisition.
Ultrafast sequences are added to the standard echocardiography acquisition.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Ministry of Health, Francecollaborator
- GIRCI IDFcollaborator
Study Sites (3)
Groupe hospitalier Paris Saint-Joseph - hôpital Marie-Lannelongue
Le Plessis-Robinson, 92350, France
AP-HP - hôpital Saint-Antoine
Paris, 75012, France
AP-HP - hôpital européen Georges-Pompidou,
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilles Soulat
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2025
First Posted
July 15, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
July 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Two years after the last publication
- Access Criteria
- Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.