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Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery

Primary Purpose

Mitral Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mitral valve replacement
Speckle tracking echocardiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mitral Regurgitation focused on measuring mitral, regurgitation, speckle, echocardiography, replacement

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with rheumatic severe mitral regurgitation who will have mitral valve replacement in Assiut University Heart Hospital

Exclusion Criteria:

  • Degenerative mitral regurgitation, ischemic mitral regurgitation, severe rheumatic mitral regurgitation with atrial fibrillation or impaired left ventricular ejection fraction, associated mitral stenosis, or significant aortic regurgitation and ischemic heart disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Valve replacement according to guideline parameters

    Early valve replacement

    Arm Description

    One group will be referred for surgery according according to indications for mitral valve replacement in European guidelines for valvular heart diseases published in 2017 and will have speckle tracking echocardiography before surgery and 6 months later for comparison.

    The other group will include patients with severe asymptomatic mitral regurgitation who have left atrial or left ventricular dysfunction according to speckle tracking echocardiography and will be referred to surgery, then speckle tracking echo will be performed 6 months later.

    Outcomes

    Primary Outcome Measures

    Recovery of left atrial functions (conduit, reservoir and booster contractile functions) and left ventricular function (global longitudinal strain) by speckle tracking echocardiography after mitral valve replacement
    Speckle tracking echocardiography will be performed 6 months after surgery to assess recovery of left atrial function by assessment of conduit, reservoir and booster contractile functions and left ventricular function by assessment of global longitudinal strain after mitral valve replacement

    Secondary Outcome Measures

    Number of patients with major adverse cardiovascular events (MACE)
    Quantifying patients with CVD events, admission for HF, ischemic cardiovascular events, cardiac death, or MACE within 6 months after surgery

    Full Information

    First Posted
    March 8, 2019
    Last Updated
    May 22, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03870516
    Brief Title
    Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery
    Official Title
    Assessment of Subclinical Left Atrial and Left Ventricular Dysfunction by Speckle Tracking Echocardiography in Severe Asymptomatic Rheumatic Mitral Regurgitation and Its Role in Predicting Outcome After Valve Replacement Compared to Guideline Parameters
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 20, 2021 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study aims to analyze the role of left ventricular and left atrial functional parameters by speckle tracking echocardiography in predicting outcome after mitral valve replacement and targeting for early intervention compared to guideline parameters.
    Detailed Description
    Without surgical treatment, the 10-year morbidity and mortality for patients with severe mitral regurgitation can be as high as 90%. In contrast, with successful surgical correction of mitral regurgitation before the appearance of symptoms, patients may have life expectancies similar to that of the general population. According to European recommendations, mitral valve replacement must be proposed to symptomatic patients and to patients with significant left ventricular remodeling as a consequence of the severity of mitral regurgitation. A significant decline in left ventricular function is defined, in these recommendations, echocardiographically as an left ventricular ejection fraction < 60% or an left ventricular end-systolic diameter > 45 mm. Preoperative left ventricular systolic function and left ventricular end systolic diameter are important postoperative prognostic factors. The early detection of left ventricular systolic dysfunction remains a challenge. Mitral regurgitation causes low left ventricular afterload, and the ejection fraction thus remains normal or supernormal until the disease reaches an advanced stage. Some authors have suggested the additive value of deformation indices as more sensitive than the ejection fraction to detect subclinical left ventricular systolic dysfunction Speckle tracking echocardiography has been well validated as a quantitative assessment tool for left ventricular function, and more recently this technique has been described for assessment of regional and global left atrial function

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mitral Regurgitation
    Keywords
    mitral, regurgitation, speckle, echocardiography, replacement

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients with rheumatic severe mitral regurgitation
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Valve replacement according to guideline parameters
    Arm Type
    Placebo Comparator
    Arm Description
    One group will be referred for surgery according according to indications for mitral valve replacement in European guidelines for valvular heart diseases published in 2017 and will have speckle tracking echocardiography before surgery and 6 months later for comparison.
    Arm Title
    Early valve replacement
    Arm Type
    Active Comparator
    Arm Description
    The other group will include patients with severe asymptomatic mitral regurgitation who have left atrial or left ventricular dysfunction according to speckle tracking echocardiography and will be referred to surgery, then speckle tracking echo will be performed 6 months later.
    Intervention Type
    Procedure
    Intervention Name(s)
    Mitral valve replacement
    Intervention Description
    Replacing the diseased mitral valve in cases with severe mitral regurgitation with a prosthetic valve.
    Intervention Type
    Device
    Intervention Name(s)
    Speckle tracking echocardiography
    Intervention Description
    We will perform Speckle tracking echocardiography in order to identify patients with early subclinical left ventricular or left atrial dysfunction and refer them to surgery, Then after surgery, speckle tracking echocardiography will be performed for all patients to assess improvement of left atrial (conduit, reservoir and booster contractile functions) and left ventricular (global longitudinal strain) function
    Primary Outcome Measure Information:
    Title
    Recovery of left atrial functions (conduit, reservoir and booster contractile functions) and left ventricular function (global longitudinal strain) by speckle tracking echocardiography after mitral valve replacement
    Description
    Speckle tracking echocardiography will be performed 6 months after surgery to assess recovery of left atrial function by assessment of conduit, reservoir and booster contractile functions and left ventricular function by assessment of global longitudinal strain after mitral valve replacement
    Time Frame
    6 months after surgery
    Secondary Outcome Measure Information:
    Title
    Number of patients with major adverse cardiovascular events (MACE)
    Description
    Quantifying patients with CVD events, admission for HF, ischemic cardiovascular events, cardiac death, or MACE within 6 months after surgery
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with rheumatic severe mitral regurgitation who will have mitral valve replacement in Assiut University Heart Hospital Exclusion Criteria: Degenerative mitral regurgitation, ischemic mitral regurgitation, severe rheumatic mitral regurgitation with atrial fibrillation or impaired left ventricular ejection fraction, associated mitral stenosis, or significant aortic regurgitation and ischemic heart disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed M. Reda
    Phone
    01007041335
    Email
    mreda30688@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Abdelhafez, MD
    Phone
    01065889346
    Email
    mohamed.abdelhafez@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy Shamseddin, PhD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19041577
    Citation
    Lancellotti P, Cosyns B, Zacharakis D, Attena E, Van Camp G, Gach O, Radermecker M, Pierard LA. Importance of left ventricular longitudinal function and functional reserve in patients with degenerative mitral regurgitation: assessment by two-dimensional speckle tracking. J Am Soc Echocardiogr. 2008 Dec;21(12):1331-6. doi: 10.1016/j.echo.2008.09.023.
    Results Reference
    background
    PubMed Identifier
    21459016
    Citation
    Marciniak A, Sutherland GR, Marciniak M, Kourliouros A, Bijnens B, Jahangiri M. Prediction of postoperative left ventricular systolic function in patients with chronic mitral regurgitation undergoing valve surgery--the role of deformation imaging. Eur J Cardiothorac Surg. 2011 Nov;40(5):1131-7. doi: 10.1016/j.ejcts.2011.02.049. Epub 2011 Apr 1.
    Results Reference
    background
    PubMed Identifier
    19258177
    Citation
    Vianna-Pinton R, Moreno CA, Baxter CM, Lee KS, Tsang TS, Appleton CP. Two-dimensional speckle-tracking echocardiography of the left atrium: feasibility and regional contraction and relaxation differences in normal subjects. J Am Soc Echocardiogr. 2009 Mar;22(3):299-305. doi: 10.1016/j.echo.2008.12.017.
    Results Reference
    background
    PubMed Identifier
    19200402
    Citation
    Cameli M, Caputo M, Mondillo S, Ballo P, Palmerini E, Lisi M, Marino E, Galderisi M. Feasibility and reference values of left atrial longitudinal strain imaging by two-dimensional speckle tracking. Cardiovasc Ultrasound. 2009 Feb 8;7:6. doi: 10.1186/1476-7120-7-6.
    Results Reference
    background

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    Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery

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