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

NCT ID: NCT03870516

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2023-09-30

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

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Valve replacement according to guideline parameters

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.

Group Type: PLACEBO_COMPARATOR

Mitral valve replacement

Intervention Type: PROCEDURE

Replacing the diseased mitral valve in cases with severe mitral regurgitation with a prosthetic valve.

Speckle tracking echocardiography

Intervention Type: DEVICE

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

Early valve replacement

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.

Group Type: ACTIVE_COMPARATOR

Mitral valve replacement

Intervention Type: PROCEDURE

Replacing the diseased mitral valve in cases with severe mitral regurgitation with a prosthetic valve.

Speckle tracking echocardiography

Intervention Type: DEVICE

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

Interventions

Mitral valve replacement

Replacing the diseased mitral valve in cases with severe mitral regurgitation with a prosthetic valve.

Intervention Type: PROCEDURE

Speckle tracking echocardiography

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed M. Reda Abdelaziz

physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamdy Shamseddin, PhD

Role: STUDY_CHAIR

Assiut University

Central Contacts

Mohamed M. Reda

Role: CONTACT

mreda30688@aun.edu.eg

01007041335

Mohamed Abdelhafez, MD

Role: CONTACT

mohamed.abdelhafez@aun.edu.eg

01065889346

References

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.

Reference Type: BACKGROUND

PMID: 19041577 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21459016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19258177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19200402 (View on PubMed)

Other Identifiers

Speckle tracking echo

Identifier Type: -

Identifier Source: org_study_id