3D Ultrasound Myocardial Mechanical Wave Measurements

NCT06648577 | Recruiting

• 2 other identifiers: APHP 240537IDRCB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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)

Conditions

Chronic Primary Mitral Regurgitation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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

  baseline

• To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity, left ventricular mass and global longitudinal strain

  baseline

Other Outcomes (2)

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

  1 year

• To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and mitral regurgitation severity

  1 year

Study Arms (1)

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

Interventions

Ultrasound imaging PROCEDURE

The participants are scanned with an ultrasound scanner

Comprehensive 2D/3D echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Pitié Salpêtrière hospital

Paris, Paris, 75013, France

RECRUITING

Pitié- Salpêtrière hospital (AP-HP)

Paris, Paris, 75013, France

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 32861651 RESULT

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Nadjib Hammoudi, MD, PhD

CONTACT

+33142163013; nadjib.hammoudi@aphp.fr

Sebastien Salles, PhD

CONTACT

sebastien.salles@cnrs.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 18, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 14, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

FR (2)