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临床试验/NCT04218578
NCT04218578已完成不适用

Association of Global Longitudinal Strain and Global Constructive Work With Cardiac Performance and Clinical Outcome One Year After MitraClip Implantation in Functional Mitral Regurgitation

University of Athens1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Changes of LV volumes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Changes of LV volumes

时间窗: 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

时间窗: one year

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

次要结局

  • Changes of myocardial work of the LV(one year)

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignatios Ikonomidis

associate professor

University of Athens

研究点 (1)

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