Not yet recruitingNAINTERVENTIONAL

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

This study is looking into how we measure a common heart valve problem called mitral regurgitation, where the heart's mitral valve leaks. Currently, doctors use ultrasound scans (echocardiography) and a type of MRI scan (2D MRI) to see how much the valve is leaking. This study wants to see if a newer, more advanced MRI scan called 4D MRI, which looks at blood flow in three dimensions and over time, can provide a more accurate picture. Researchers will compare all three types of scans to see which one best shows how the heart changes over six months, as this helps doctors decide on the best treatment.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

160

Start

01 Oct 2025

Estimated completion

30 Apr 2028

Mitral Regurgitation (MR)

What is this study about?

This study is about a common heart condition called mitral regurgitation, which means one of the heart's valves, the mitral valve, isn't closing properly and allows blood to leak backwards. Doctors need a very accurate way to measure how much blood is leaking, as this helps them decide if and when a patient might need treatment.

Currently, the main ways to measure this are using heart ultrasound scans (called echocardiography) and a specific type of MRI scan (called 2D MRI). While these are helpful, they have some drawbacks. Echocardiography can sometimes be tricky to get clear pictures, and 2D MRI needs specialist expertise. There's a newer, more advanced MRI scan called 4D MRI that looks at blood flow in more detail, in all directions, and over time. It's shown promise in other heart valve problems, but we don't yet know if it's better for mitral regurgitation.

So, this study wants to find out if 4D MRI is better at measuring the leak from the mitral valve compared to the standard methods. The main question is: does the leak measurement from 4D MRI link more closely to how a patient's heart changes over time (what doctors call 'remodeling') than the measurements from 2D MRI and echocardiography? If 4D MRI proves to be more accurate, it could eventually help doctors make better decisions about care for people with mitral regurgitation.

Key takeaways

This study compares standard heart scans with a new 4D MRI scan.
It's for people with a leaky heart valve (mitral regurgitation).
The goal is to find the best way to track how your heart changes over time.
Participation involves having different heart scans twice over six months.
There are no new treatments or medications involved in this study.

Who may be eligible?

You might be able to take part in this study if you are between 18 and 85 years old. You should have been told you have a leaky mitral valve (mitral regurgitation), whether it's mild, moderate, or severe, based on a previous ultrasound scan.

It's important that you are able to have both ultrasound and MRI scans. These scans would need to be done within 7 days of joining the study, and then again after six months. You'll also need to be able to understand and sign a consent form, showing you agree to take part.

You would NOT be able to take part if you have other specific heart valve problems (like problems with your aortic valve or mitral stenosis), or if you have a pacemaker, defibrillator, or other reasons that make MRI scans unsafe for you. People with severe kidney disease, those who are pregnant or breastfeeding, or individuals unable to understand the study would also not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Have you been diagnosed with a leaky mitral valve (mitral regurgitation)?
Are you able to have both ultrasound and MRI scans?
Do you NOT have a pacemaker, defibrillator, or serious kidney problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have specific heart scans at the beginning and then again six months later. These scans will include a standard heart ultrasound (echocardiography), a 2D MRI scan, and the newer 4D MRI scan. All these scans will be performed within a week of starting the study and then repeated at the six-month mark. There are no study medications involved. The total duration of your active participation will be six months, during which researchers will monitor how your heart changes.

Potential risks and benefits

Taking part in this study might benefit you by helping doctors understand which imaging method is best for monitoring your heart condition, which could lead to better future care for people with mitral regurgitation. The main risks involve undergoing MRI scans, which can sometimes be noisy or cause claustrophobia. There's also a small risk associated with the contrast dye used in some MRI scans, though this will be explained to you. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (3)

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

Common questions

What is mitral regurgitation?

Mitral regurgitation is a condition where one of your heart valves, the mitral valve, doesn't close completely, causing blood to leak backward when your heart beats.

What is a 4D MRI scan?

A 4D MRI is an advanced type of MRI scan that allows doctors to see how blood flows through your heart in three dimensions and over time, like a moving picture.

Why is this study important?

This study aims to find the best way to measure a leaky heart valve, which could help doctors better monitor the condition and make more informed decisions about treatment.

Will I receive any new treatment in this study?

No, this study is comparing different ways to scan your heart; it does not involve any new medications or treatments.

How long will I be involved in the study?

Your involvement in the study will last for six months, with scans performed at the beginning and at the six-month mark.

How to find out more

Maxime Brussieux

maxime.brussieux@aphp.fr +33 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.