Heart Failure, Mitral Regurgitation
Conditions
Keywords
MitraClip, Functional mitral regurgitation, Reverse remodeling
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTspeckle tracking analysis of transthoracic echocardiogram
analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination
Sponsors
University of Athens
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of LV volumes | one year | change of left ventricular end-diastolic and end-systolic volumes during one-year follow up of the patients |
| Changes of NYHA class status | one year | measurement of NYHA class status at baseline and one-year follow uo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of myocardial work of the LV | one year | Evaluation of the components of myocardial work (Global work index, global constructive work, Global wasted Work and Global Work efficiency) at baseline and one-year follow up |
Countries
Greece
Outcome results
None listed