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3D Ultrasound Myocardial Mechanical Wave Measurements

3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06648577
Acronym
3DUsMR
Enrollment
40
Registered
2024-10-18
Start date
2024-10-09
Completion date
2027-11-14
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Primary Mitral Regurgitation

Keywords

Primary mitral regurgitation, High frame rate ultrasound imaging, CMR, Myocardial fibrosis

Brief summary

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)

Detailed description

After being informed about the study. All patients giving written informed consent will undergo in a routine practice: 1. echocardiography (2D/3D), 2. CMR imaging, 3. electrocardiogram 24 hours monitoring, 4. blood sampling including brain natriuretic peptide measurement, 5. symptom-limited combined exercise echocardiography and oxygen uptake measurements

Interventions

PROCEDUREUltrasound imaging

The participants are scanned with an ultrasound scanner

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

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

MeasureTime frameDescription
To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and exercice capacity1 yearThe 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 severity1 yearThe 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).

Countries

France

Contacts

Primary ContactNadjib Hammoudi, MD, PhD
nadjib.hammoudi@aphp.fr+33142163013
Backup ContactSebastien Salles, PhD
sebastien.salles@cnrs.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026