Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM) — COHORTE-IM  

Mitral Valve Insufficiency Clinical Trial

Official title: Prognostic Impact of Non-invasive Imaging Parameters (Cardiac Echocardiography and MRI) in Patients With Primary Mitral Insufficiency (MI) by Prolapse: Observational Cohort, Monocentric (COHORTE-IM)

Status Recruiting

Clinical Trial Summary

Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., with high risk of morbi-mortality during their follow-up).

It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.

A number of echocardiographic and MRI parameters may have been associated with a poorer prognosis.

A cohort of patients with primary mitral insufficiency (MI) will be followed to study the relationships of a set of factors to patient prognosis.

Clinical Trial Description

Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., at high risk of morbi-mortality during their follow-up).

It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.

Beyond the regurgitation severity parameters, a number of regurgitation resonance parameters may have been associated with a poorer prognosis. These parameters include dilation of the left ventricle (increase of telesystolic diameter), of the left atrium, decrease of left ventricular ejection fraction (FE VG), and increase of pulmonary pressures (pulmonary hypertension). The relationship between left, right ventricular function, atrial function evaluated by new echocardiographic techniques (Speckle tracking, 3D) and prognosis has been poorly studied.

These new innovative techniques are now available in clinical routine and allow an evaluation of size and cardiac function parameters in a more reproducible way than conventional methods. The relationship between prognosis and the assessment of regurgitation severity by the convergence zone method (PISA method) has been well documented in the literature. However, the PISA method presents well-documented reproducibility problems. Other methods of quantification exist, either by echocardiography (qualitative, semi-quantitative and quantitative methods) or by MRI (quantitative methods). They are useful in clinical practice in a multiparametric approach, but their relationship to prognosis has been not well studied.

Thus, the prognostic impact of the following parameters must be studied:

• Echocardiographic and MRI parameters of primary insufficiency severity and their combination

• Ventricular and atrial functions measured by innovative echocardiographic methods (speckle tracking, 3D, left ventricular ejection performance parameters)

• The remodeling of cardiac cavities related to mitral insufficiency evaluated by echocardiography and MRI, apart from the diameter of the left ventricle and the size of the left atrium that has already been studied.

A cohort of patients with primary mitral insufficiency (MI) will be followed up to study the relationships of all these factors with patient prognosis. Part of this cohort will be retrospective, and part will be prospective. ;

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Prolapse

• NCT number: NCT03962023
• Study type: Observational [Patient Registry]
• Source: Lille Catholic University
• Contact: Marie Paule LEBITASY, Md
• Phone: +33 3 20 22 52 69
• Email: lootens.livia@ghicl.net
• Status: Recruiting
• Start date: September 4, 2019
• Completion date: September 2034