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Completed

NCT Number: NCT04218578

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

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Attikon University Hospital of Athens

Athens, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

speckle tracking analysis of transthoracic echocardiogram

Diagnostic Test

analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination

Primary outcomes

  1. Changes of LV volumes

    Time frame: one year

    change of left ventricular end-diastolic and end-systolic volumes during one-year follow up of the patients

  2. Changes of NYHA class status

    Time frame: one year

    measurement of NYHA class status at baseline and one-year follow uo

Secondary outcomes

  1. Changes of myocardial work of the LV

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2020
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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