NCT06648577 3D Ultrasound Myocardial Mechanical Wave Measurements
| NCT ID | NCT06648577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Chronic Primary Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-10-09 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06648577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Primary Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06648577 currently recruiting?
Yes, NCT06648577 is actively recruiting participants. Contact the research team at nadjib.hammoudi@aphp.fr for enrollment information.
Where is the NCT06648577 trial being conducted?
This trial is being conducted at Paris, France, Paris, France.
Who is sponsoring the NCT06648577 clinical trial?
NCT06648577 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 40 participants.