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L'essai clinique NCT06648577 (3DUsMR) pour Chronic Primary Mitral Regurgitation est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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3D Ultrasound Myocardial Mechanical Wave Measurements (3DUsMR)

En recrutement
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L'étude clinique NCT06648577 (3DUsMR) est un essai observationnel pour Chronic Primary Mitral Regurgitation. Son statut actuel est : en recrutement. L'étude a débuté le 9 octobre 2024 et vise à recruter 40 participants. Dirigé par l'Assistance publique - Hôpitaux de Paris, l'essai devrait être terminé d'ici le 14 novembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 18 novembre 2025.
Résumé succinct
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)

Description détaillée

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
Titre officiel

3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation

Conditions
Chronic Primary Mitral Regurgitation
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • 3DUsMR
  • APHP 240537
  • IDRCB (Autre Identifiant) (2024-A01637-40)
Numéro NCT
NCT06648577
Date de début (réel)
2024-10-09
Dernière mise à jour publiée
2025-11-18
Date de fin (estimée)
2027-11-14
Inscription (estimée)
40
Type d'essai
Observationnel
Statut
En recrutement
Mots clés
Primary mitral regurgitation
High frame rate ultrasound imaging
CMR
Myocardial fibrosis
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
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.
Imagerie par ultrasons
The participants are scanned with an ultrasound scanner
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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)

  • 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
Assistance Publique - Hôpitaux de Paris logoAssistance publique - Hôpitaux de Paris961 essais cliniques actifs à explorer
Contact central de l'essai
Contact: Nadjib Hammoudi, MD, PhD, +33142163013, [email protected]
Contact: Sebastien Salles, PhD, [email protected]
2 Centres de l'essai dans 1 pays

Paris

Pitié Salpêtrière hospital, Paris, Paris, 75013, France
En recrutement
Pitié- Salpêtrière hospital (AP-HP), Paris, Paris, 75013, France
Nadjb Hammoudi, MD, PhD, Contact, +33142163013, [email protected]
Pas encore en recrutement