Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip

National and Kapodistrian University of Athens

Status: Completed

Conditions: Mitral Regurgitation; Heart Failure

Treatments: Diagnostic Test: speckle tracking analysis of transthoracic echocardiogram

Study type: Observational

Funder types: Other

Identifiers

NCT04218578

card,EBD308/10-05-2018

Details and patient eligibility

About

The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.

Full description

This study is one of the first in terms of publication. As far as the investigators know there are few papers with small series of patients regarding echocardiographic parameters and strain imaging in patients with functional mitral regurgitation (MR) and MitraClip. As the investigator's goal is to assess the potential impact of the MitraClip on myocardial deformation indexes, at the end of the study a direct comparison of changes of echocardiography markers -at one year follow up- between the control and device group will be performed. The changes in myocardial deformation markers will be associated with the respective changes in Brain-natriuretic peptide (BNP) levels, New York Heart Association (NYHA) class status, 6-minute walking distance (6MWD) and left ventricle (LV) volumes at follow -up. The investigators also aim to identify baseline prognostic echocardiography markers for the prediction of clinical improvement and LV reverse remodeling after successful edge-to-edge repair in functional MR patients during one year follow up. In specific, in this study the investigators will measure the 2-Dimension (2D) strain values of the left ventricle and left atrium (global longitudinal strain-GLS of the LV and Peak Atrial longitudinal strain - PALS of the left atrium) at baseline and at one year follow up, they will appreciate the LV myocardial work and all its components (Global Work Index-GWI, Global Constructed Work-GCW,Global wasted work-GWW and Global Work Efficiency-GWE) of the left ventricle and finally they will evaluate the baseline variables as predictors of reverse LV remodeling defined by reduction of left ventricle end-diastolic and end-systolic volume at one-year follow up.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with EF more than 15% and below 45%
• Heart failure symptoms with NYHA class >2
• Moderate-to-severe and severe functional Mitral regurgitation

Exclusion criteria

• degenerative mitral regurgitation
• asymptomatic patients
• NYHA class IV patients not able to perform 6MWT
• EF>45%
• poor echocardiographic acoustic window patients

Trial design

100 participants in 2 patient groups

Device group

Description:

patients with heart failure and concomitant severe functional mitral regurgitation that were treated with MitraClip

Treatment:

Diagnostic Test: speckle tracking analysis of transthoracic echocardiogram

Control group

Description:

patients with heart failure and concomitant severe functional mitral regurgitation that were treated with optimal medical treatment

Treatment:

Diagnostic Test: speckle tracking analysis of transthoracic echocardiogram