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NCT Number: NCT06648577

3D Ultrasound Myocardial Mechanical Wave Measurements

Primary mitral regurgitation (MR) is a frequent disease that can ultimately lead to heart failure. Primary MR represents the second most prevalent cause of cardiac valve surgery in high income countries. Progressive myocardial fibrosis due to chronic volume overload is recognized as a pathophysiological substrate of altered LV function in primary MR. As fibrosis leads to increased myocardial stiffness, ultrasound mechanical wave propagation measurements within the myocardium could provide important clinical information. Natural mechanical wave velocity (MWV) imaging, using High-frame-rate (HFR) echocardiography has emerged as a promising tool to evaluate myocardial stiffness.

The objective is study is to evaluate the correlation between the LV myocardial stiffness (as assessed by 3D ultrasound myocardial MWV mapping) and myocardial interstitial fibrosis as measured using CMR (myocardial extracellular volume measure)

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Key information

Conditions

Chronic Primary Mitral Regurgitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pitié Salpêtrière hospital, Paris, France

About this study

After being informed about the study. All patients giving written informed consent will undergo in a routine practice:

echocardiography (2D/3D),
CMR imaging,
electrocardiogram 24 hours monitoring,
blood sampling including brain natriuretic peptide measurement,
symptom-limited combined exercise echocardiography and oxygen uptake measurements

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) with class I indication for surgery (symptoms and/or altered conventional parameters of LV function) (n=10 patients)
Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) without class I indication of surgery (n=20 patients)
Mild to moderate primary MR patients as defined by effective regurgitation orifice area ≥ 20mm² and < 40mm² (n=10 patients)

Exclusion criteria

Permanent atrial fibrillation
Acute primary severe MR
Secondary MR
Previous cardiac surgery of any kind
Other severe left sided valvular disease
Coronary artery disease
Congenital cardiac disorder

Treatment and study plan

Ultrasound Imaging

Procedure

The participants are scanned with an ultrasound scanner

Primary outcomes

To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (ECV measure).

Time frame: baseline

The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging.

Left ventricular interstitial fibrosis will be assessed by the measure of myocardial extracellular volume fraction (ECV, in %) by CMR.

Secondary outcomes

To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (T1 mapping)

Time frame: baseline

The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging.

Left ventricular fibrosis will be assessed from CMR by pre and post contrast T1 mapping (in milliseconds)
To assess the link between left ventricular stiffness as assessed by 3D Mechanical wave velocity and the 3 different clinical stages of chronic mitral regurgitation

Time frame: baseline
The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging.

The clinical stages of the patients are defined as follow:
- Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) with class I indication for surgery (symptoms and/or altered LV function as defined by left ventricular ejection fraction ≤60% and/or left ventricular end systolic diameter ≥40mm) (n=10 patients)
- Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) without class I indication of surgery (n=20 patients)
- Mild to moderate primary MR patients as defined by effective regurgitation orifice area ≥ 20mm² and < 40mm² (n=10 patients)
To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity, left ventricular mass and global longitudinal strain

Time frame: baseline

The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging.

Left ventricular mass will be measured (in grammes /m²) using echocardiography and CMR Global longitudinal strain (in %) will be measured from echocardiography and CMR from apical 4, 2 and 3 chambers views.

Other outcomes

To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and exercice capacity

Time frame: 1 year

The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging.

The exercise capacity will be measured thought symptom-limited combined exercise echocardiography and oxygen uptake measurements (in watts and using peak oxygen uptake expressed as mL/kg)
To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and mitral regurgitation severity

Time frame: 1 year

The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging.

Mitral regurgitation severity will be assessed by echocardiography (effective regurgitation orifice area in mm² and regurgitation volume in mL) and using CMR (regurgitation orifice area, volume and regurgitation fraction).

Study contacts

Contact information is provided by the study sponsor or research team.

Nadjib Hammoudi, MD, PhD

CONTACT

[email protected]

+33142163013

Sebastien Salles, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation

Acronym: 3DUsMR

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Oct 18, 2024
Registry last updated: Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.