Clinical trial NCT06067815: Assessment of Right Ventricular Function in Patients With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
Official title: Assessment of Right Ventricular Function in Patient With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mitral Stenosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe mitral stenosis,not impairment left ventricular function

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To compare RV function before and after PTMC
timeFrame: 1 year
Secondary outcomes:
measure: To measure the right side pressure changes invasively before and after PTMC
timeFrame: 1 year
measure: To compare the effect of PTMC on RV function in patient with AF and sinus rythm
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.