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

Mitral Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06067815
• Other study ID #: Mitral stenosis PTMC
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Yassmin Zakaria Basheir
• Phone: 01115429471
• Email: Yass.min97[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Mitral Stenosis
• Mitral Valve Stenosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Kumar V, Jose VJ, Pati PK, Jose J. Assessment of right ventricular strain and strain rate in patients with severe mitral stenosis before and after balloon mitral valvuloplasty. Indian Heart J. 2014 Mar-Apr;66(2):176-82. doi: 10.1016/j.ihj.2014.02.012. Epub 2014 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare RV function before and after PTMC	echocardiogram	1 year
Secondary	To measure the right side pressure changes invasively before and after PTMC	Right sided heart catheterization	1 year
Secondary	To compare the effect of PTMC on RV function in patient with AF and sinus rythm		1year