Clinical trial NCT04218578: Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip
Official title: Association of Global Longitudinal Strain and Global Constructive Work With Cardiac Performance and Clinical Outcome One Year After MitraClip Implantation in Functional Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Heart Failure
Keywords: MitraClip
Functional mitral regurgitation
Reverse remodeling
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: heart failure patients with severe functional mitral regurgitation that are treated either with MitraClip or with optimal medical treatment

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of LV volumes
timeFrame: one year
measure: Changes of NYHA class status
timeFrame: one year
Secondary outcomes:
measure: Changes of myocardial work of the LV
timeFrame: one year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon University Hospital of Athens
Study officials:
affiliation: Attikon University Hospital of Athens
name: Ignatios Ikonomidis, Professor
role: STUDY_CHAIR
References:
citation: Papadopoulos K, Ikonomidis I, Chrissoheris M, Chalapas A, Kourkoveli P, Parissis J, Spargias K. MitraClip and left ventricular reverse remodelling: a strain imaging study. ESC Heart Fail. 2020 Aug;7(4):1409-1418. doi: 10.1002/ehf2.12750. Epub 2020 May 20.