Right Ventricular Echo Assessment in Mitral Valve Replacement

NCT03549052 | Unknown

• 1 other identifier: Echo in mitral valve diseases
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Right Ventricular Dysfunction; Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

• The correlation between echocardiographic parameters of the RV, measured with TTE , preoperative and short term post operative

  change in TAPSE (Tricuspid annular plane systolic excursion )

  Baseline-1 Week-3 months

Secondary Outcomes (6)

• postoperative Response in right ventricular function parameter S' Change in S'

  Baseline-1 Week-3 months

• Postoperative Response in right ventricular function parameter RVFAC

  Baseline-1 Week-3 months

• Postoperative Response in right ventricular function parameter pulmonary artery systolic pressure

  Baseline-1 Week-3 months

• Postoperative right atrial pressure assesment

  Baseline-1 Week-3 months

• Evaluation of reverse right ventricle (RV) remodelling

  Baseline-1 Week-3 months

Other Outcomes (2)

• NYHA Class

  3 months

• Mortality

  up to 3 months of intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who presented to our department of Cardiothoracic surgery, Assiut University hospitals from May 2018 to April 2020 and who are candidate for mitral valve replacement and meet the listed inclusion and exclusion criteria will be eligible for the study. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base, for later data analysis.

You may qualify if:

• All ages will be accepted.
• Isolated mitral valve lesion either stenosis or regurge.
• Good LV function (EF \<45%).
• Any degree of tricuspid valve regurge..

You may not qualify if:

• Concomitant Aortic valve lesion needs replacement.
• Poor LV function (Low EF\> 45%).
• Other causes of pulmonary hypertension i.e.: (Chronic obstructive or restrictive pulmonary disease, connective tissue disease and chronic thromboembolism).
• Emergency and Redo operations.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Naeije R. Assessment of right ventricular function in pulmonary hypertension. Curr Hypertens Rep. 2015 May;17(5):35. doi: 10.1007/s11906-015-0546-0.

  PMID: 25833458 RESULT

• Kjaergaard J. Assessment of right ventricular systolic function by tissue Doppler echocardiography. Dan Med J. 2012 Mar;59(3):B4409.

  PMID: 22381093 RESULT

• Ling LF, Marwick TH. Echocardiographic assessment of right ventricular function: how to account for tricuspid regurgitation and pulmonary hypertension. JACC Cardiovasc Imaging. 2012 Jul;5(7):747-53. doi: 10.1016/j.jcmg.2011.08.026. No abstract available.

  PMID: 22789943 RESULT

• Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

  PMID: 20620859 RESULT

• Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.

  PMID: 19151265 RESULT

• Magne J, Pibarot P, Sengupta PP, Donal E, Rosenhek R, Lancellotti P. Pulmonary hypertension in valvular disease: a comprehensive review on pathophysiology to therapy from the HAVEC Group. JACC Cardiovasc Imaging. 2015 Jan;8(1):83-99. doi: 10.1016/j.jcmg.2014.12.003.

  PMID: 25592699 RESULT

• Bayat F, Aghdaii N, Farivar F, Bayat A, Valeshabad AK. Early hemodynamic changes after mitral valve replacement in patients with severe and mild pulmonary artery hypertension. Ann Thorac Cardiovasc Surg. 2013;19(3):201-6. doi: 10.5761/atcs.oa.11.01865. Epub 2012 Oct 15.

  PMID: 23064658 RESULT

• Kret M, Arora R. Pathophysiological basis of right ventricular remodeling. J Cardiovasc Pharmacol Ther. 2007 Mar;12(1):5-14. doi: 10.1177/1074248406298293.

  PMID: 17495253 RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, Right; Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Ahmed M. EL_Minshawy, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed M. Nasr, Msc

CONTACT

01005582003; Nasr1987.cts@gmail.com

Ahmed M. Fathy Ghoneim, Professor

CONTACT

01001215565; ahghoneim@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer Cardiothoracic surgery

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 7, 2018
• Study Start: June 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: January 1, 2020
• Last Updated: June 7, 2018

Record last verified: 2018-06