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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-15

No results posted yet for this 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.

Conditions

  • Mitral Regurgitation (MR)

Interventions

DIAGNOSTIC_TEST

Standard echocardiography

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Cardiac ultrafast ultrasound imaging

Ultrafast sequences are added to the standard echocardiography acquisition.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • GIRCI IDF

    collaborator UNKNOWN
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gilles Soulat · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066904 on ClinicalTrials.gov