3D ultrasound mapping of heart muscle wave speed
3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation
This study will test whether 3D high‑frame‑rate ultrasound mapping of myocardial mechanical wave velocity can detect left‑ventricular stiffness in adults with primary mitral regurgitation compared with CMR measures of fibrosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris, Paris and 1 other locations) |
| Trial ID | NCT06648577 on ClinicalTrials.gov |
What this trial studies
This is an observational, single‑center imaging study enrolling about 40 patients with varying severity of primary mitral regurgitation. Participants undergo 2D/3D echocardiography including high‑frame‑rate mechanical wave velocity (MWV) mapping, cardiac magnetic resonance imaging to measure extracellular volume (ECV), 24‑hour ECG monitoring, blood tests including BNP, and symptom‑limited exercise echocardiography with oxygen uptake. The primary approach is to correlate 3D ultrasound MWV maps with CMR‑derived ECV as a marker of interstitial myocardial fibrosis. The goal is to determine whether MWV mapping by ultrasound reflects myocardial stiffness related to chronic volume overload from mitral regurgitation.
Who should consider this trial
Good fit: Adults with primary mitral regurgitation (mild‑to‑moderate or severe) who meet the study's echocardiographic criteria and do not have prior cardiac surgery, permanent atrial fibrillation, coronary artery disease, or other major left‑sided valvular disease are ideal candidates.
Not a fit: Patients with secondary or acute severe mitral regurgitation, permanent atrial fibrillation, prior cardiac surgery, congenital heart disease, or significant coronary artery disease are excluded and unlikely to benefit from this imaging comparison.
Why it matters
Potential benefit: If successful, this could provide a quick, noninvasive ultrasound marker of myocardial stiffness to help guide timing of surgery or monitor myocardial changes.
How similar studies have performed: High‑frame‑rate ultrasound MWV imaging has shown promise in early pilot studies as a stiffness marker, but comprehensive 3D MWV mapping correlated with CMR ECV is novel and supported only by limited small‑scale data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, Paris and 1 other locations
- Pitié Salpêtrière hospital — Paris, Paris, France (Recruiting)
- Pitié- Salpêtrière hospital (AP-HP) — Paris, Paris, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Nadjib Hammoudi, MD, PhD
- Email: nadjib.hammoudi@aphp.fr
- Phone: +33142163013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.