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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03870516
Enrollment
100
Registered
2019-03-12
Start date
2021-09-20
Completion date
2023-09-30
Last updated
2020-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

mitral, regurgitation, speckle, echocardiography, replacement

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

Interventions

PROCEDUREMitral valve replacement

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

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Patients with rheumatic severe mitral regurgitation

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 replacement6 months after surgerySpeckle 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

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

Contacts

Primary ContactMohamed M. Reda
mreda30688@aun.edu.eg01007041335
Backup ContactMohamed Abdelhafez, MD
mohamed.abdelhafez@aun.edu.eg01065889346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026