Assessment of Right Ventricular Function in Patients With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty

Not yet recruiting

• Conditions: Mitral Stenosis

• Registration Number: NCT06067815
• Lead Sponsor: Assiut University

Brief Summary

To detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function

Detailed Description

In patients with mitral valve stenosis, right ventricular failure may develop either by the rheumatic process directly or through hemodynamic alterations resulting from pulmonary vascular changes.

Right ventricular (RV) function plays an important role in development of clinical symptoms and prognosis in patients with mitral stenosis (MS).This is primarily affected by hemodynamic effects on RV due to pulmonary hypertension(PH).

In the last two decades, Percutaneous Transluminal Mitral Commissurotomy (PTMC) has become the treatment of choice for patients with symptomatic rheumatic MS . Using this method,Mitral Valve Area (MVA) can be increased, which can improve the hemodynamic and clinical features of patients with MS .

RV functional assessment is difficult and not done routinely because of its complex anatomy and high load dependence.

Different modalitis are used to assess RV function as Tissue Doppler and two-dimensional (2D) speckle tracking method has been used to quantify strain for assessment Myocardial strain is a measure of tissue deformation, which is expressed as a percentage change.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study Start: 2023-10-01
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).

  • Patient with normal left ventricular EF.
  • patient with sinus rhythm or AF
  • patient with any degree of pulmonary HTN

Exclusion Criteria

• Patient with another valve lesion or more than mild mitral regurgitation.
• Patient with impaired cardiac function.
• patient with coronary arteries disease
• Mitral stenosis of other etiology than rheumatic origin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare RV function before and after PTMC	1 year	echocardiogram

Secondary Outcome Measures

Name	Time	Method
To measure the right side pressure changes invasively before and after PTMC	1 year	Right sided heart catheterization
To compare the effect of PTMC on RV function in patient with AF and sinus rythm	1year