3D Ultrasound Myocardial Mechanical Wave Measurements (3DUsMR)

3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation

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)

Study Overview

• Status: Recruiting
• Conditions: Chronic Primary Mitral Regurgitation
• Intervention / Treatment: Procedure: Ultrasound imaging

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

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Nadjib Hammoudi, MD, PhD; Phone Number: +33142163013; Email: nadjib.hammoudi@aphp.fr
• Study Contact Backup: Name: Sebastien Salles, PhD; Email: sebastien.salles@cnrs.fr

Study Locations

• France
  • Paris
    • Paris, Paris, France, 75013
      • Recruiting
      • Pitie Salpetriere Hospital
    • Paris, Paris, France, 75013
      • Not yet recruiting
      • Pitié- Salpêtrière hospital (AP-HP)
      • Contact: Nadjb Hammoudi, MD, PhD; Phone Number: +33142163013; Email: nadjib.hammoudi@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will include adult patients with chronic primary mitral regurgitation who have been referred to our tertiary cardiology center as part of their routine care. These are the typical patients with chronic primary mitral regurgitation whom we aim to better phenotype using the new 3D ultrasound mapping technology for MWV (mechanical wave velocity).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Comprehensive 2D/3D echocardiography; This an observational non interventional study. All patients will have both comprehensive 2D/3D echocardiography (including MWV imaging) and cardiac CMR.	Procedure: Ultrasound imaging; The participants are scanned with an ultrasound scanner

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (T1 mapping)	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)	baseline
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	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)	baseline
To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity, left ventricular mass and global longitudinal strain	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.	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and exercice capacity	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)	1 year
To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and mitral regurgitation severity	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).	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Salles S, Espeland T, Molares A, Aase SA, Hammer TA, Stoylen A, Aakhus S, Lovstakken L, Torp H. 3D Myocardial Mechanical Wave Measurements: Toward In Vivo 3D Myocardial Elasticity Mapping. JACC Cardiovasc Imaging. 2021 Aug;14(8):1495-1505. doi: 10.1016/j.jcmg.2020.05.037. Epub 2020 Aug 26.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 14, 2027

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CMR; Myocardial fibrosis; Primary mitral regurgitation; High frame rate ultrasound imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: APHP 240537; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No