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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06067815

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mitral Stenosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Outcome Measures

Primary Outcome Measures

To compare RV function before and after PTMC [1 year]
echocardiogram

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 70 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Yassmin Zakaria Basheir, Assessment of right ventricular function in patient with severe mitral stenosis before and after balloon mitral valvuloplasty, Assiut University

ClinicalTrials.gov Identifier:

NCT06067815

Other Study ID Numbers:

Mitral stenosis PTMC

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mitral Valve Stenosis

Constriction, Pathologic

Study Results

No Results Posted as of Oct 5, 2023