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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218578
• Other study ID #: card,EBD308/10-05-2018
• Status: Completed
• Start date: May 10, 2018
• Est. completion date: May 10, 2019

Study information

• Verified date: January 2020
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 10, 2019
• Est. primary completion date: February 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Diagnostic Test:
• speckle 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

Locations

Country	Name	City	State
Greece	Attikon University Hospital of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of LV volumes	change of left ventricular end-diastolic and end-systolic volumes during one-year follow up of the patients	one year
Primary	Changes of NYHA class status	measurement of NYHA class status at baseline and one-year follow uo	one year
Secondary	Changes of myocardial work of the LV	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	one year