Clinical trial NCT03870516: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Regurgitation
Keywords: mitral
regurgitation
speckle
echocardiography
replacement
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with rheumatic severe mitral regurgitation
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: 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
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Number of patients with major adverse cardiovascular events (MACE)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hamdy Shamseddin, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.