Right Ventricular Echo Assessment in Mitral Valve Replacement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03549052|
Recruitment Status : Unknown
Verified June 2018 by Ahmed M. Nasr, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Rheumatic heart disease remains a major health problem in developing countries. It is the most important sequel of rheumatic fever and occurs in about 30% of patients with rheumatic fever.Rheumatic heart disease presents with different degrees of pancarditis and associated valve failure. Involvement of the mitral leaflets can cause mitral regurgitation (MR) or stenosis and eventually can lead to heart failure. Mitral repair or replacement is therefore recommended before left ventricular (LV) dysfunction develops.
Study Objectives/Specific Aims Overall Goal: To determine the benefit the patient with pulmonary hypertension will get from mitral valve replacement as regard function improvement and remodeling of the right ventricle.
- Objective1: Identify risk factors that are predictive of outcomes.(Type and severity of Mitral valve pathology , severity of pulmonary hypertension, tricuspid regurge, preoperative RV dysfunction)
- Objective2: Determine the value of management strategies (Mitral valve replacement in pulmonary hypertension i.e. : decrease RV pressure overload and enhance RV remodeling)
- Objective3: Assessment of the outcomes clinically & Echocardiographically : postoperative results during hospital stay and follow up (short term up to 3 months).
|Condition or disease|
|Right Ventricular Dysfunction Rheumatic Heart Disease|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Right Ventricular Function After Mitral Valve Replacement in Rheumatic Heart Disease Patients With Pulmonary Hypertension: Short Term Follow up|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||January 2020|
- The correlation between echocardiographic parameters of the RV, measured with TTE , preoperative and short term post operative [ Time Frame: Baseline-1 Week-3 months ]change in TAPSE (Tricuspid annular plane systolic excursion )
- postoperative Response in right ventricular function parameter S' Change in S' [ Time Frame: Baseline-1 Week-3 months ]TDI (Tissue doppler imaging) across the lateral tricuspid annulus : peaked S' velocity
- Postoperative Response in right ventricular function parameter RVFAC [ Time Frame: Baseline-1 Week-3 months ]change in RVFAC : Right ventricular calculated ejection fraction by mean of change in RV systolic and diastolic volumes
- Postoperative Response in right ventricular function parameter pulmonary artery systolic pressure [ Time Frame: Baseline-1 Week-3 months ]PASP measured by CW doppler across tricusped valve regurgetant jet
- Postoperative right atrial pressure assesment [ Time Frame: Baseline-1 Week-3 months ]RA diamter and IVC collapsability in cm
- Evaluation of reverse right ventricle (RV) remodelling [ Time Frame: Baseline-1 Week-3 months ]The evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters with respect to pre-surgery
- Residual TR [ Time Frame: Baseline-1 Week-3 months ]Percentage of patients with moderate to severe TR at 3 months after surgery
- NYHA Class [ Time Frame: 3 months ]Modification of NYHA class at 3 months after surgery
- Mortality [ Time Frame: up to 3 months of intervention ]Mortality within hospital stay or 3 months postoperative.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549052
|Contact: Ahmed M. Nasr, Msc||01005582003||Nasr1987.firstname.lastname@example.org|
|Contact: Ahmed M. Fathy Ghoneim, Professoremail@example.com|
|Study Director:||Ahmed M. EL_Minshawy, Professor||Assiut University|