3D Ultrasound Myocardial Mechanical Wave Measurements

Not yet recruiting

• Conditions: Chronic Primary Mitral Regurgitation

• Registration Number: NCT06648577
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-18
• Last Update Posted: 2024-10-18
• Study Start: 2024-11-15
• Primary Completion: 2026-11-15
• Study Completion: 2027-11-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Pitié- Salpêtrière hospital (AP-HP); 🇫🇷 Paris, France