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Clinical Trials in France / NCT07066904
Starting soon Not 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

NCT07066904 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-10-01
Last updated
2025-07-15

Condition(s) studied

Mitral Regurgitation (MR)

Investigational drug(s) / intervention(s)

Standard echocardiography2D phase-contrast magnetic resonance imaging4D flow magnetic resonance imagingCardiac ultrafast ultrasound imaging

Standard echocardiography: Routine ultrasound examination with standardized recordings for the study, incorporating volumetric assessment techniques

2D phase-contrast magnetic resonance imaging: 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.

4D flow magnetic resonance imaging: 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.

Cardiac ultrafast ultrasound imaging: Ultrafast sequences are added to the standard echocardiography acquisition.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Absolute change in left ventricle end-diastolic volume — Baseline, 6 months
    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.
  • Mitral regurgitant volume — Baseline
    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.

Trial sites (3)

FacilityCityRegionStatus
Groupe hospitalier Paris Saint-Joseph - hôpital Marie-Lannelongue Le Plessis-Robinson France
AP-HP - hôpital Saint-Antoine Paris France
AP-HP - hôpital européen Georges-Pompidou, Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07066904 on ClinicalTrials.gov ↗ ← All trials in France