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Right Ventricular Echo Assessment in Mitral Valve Replacement

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ClinicalTrials.gov Identifier: NCT03549052
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed M. Nasr, Assiut University

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).

Condition or disease
Right Ventricular Dysfunction Rheumatic Heart Disease

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. 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 )


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Postoperative right atrial pressure assesment [ Time Frame: Baseline-1 Week-3 months ]
    RA diamter and IVC collapsability in cm

  5. 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

  6. Residual TR [ Time Frame: Baseline-1 Week-3 months ]
    Percentage of patients with moderate to severe TR at 3 months after surgery


Other Outcome Measures:
  1. NYHA Class [ Time Frame: 3 months ]
    Modification of NYHA class at 3 months after surgery

  2. Mortality [ Time Frame: up to 3 months of intervention ]
    Mortality within hospital stay or 3 months postoperative.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Ahmed M. Nasr, Msc 01005582003 Nasr1987.cts@gmail.com
Contact: Ahmed M. Fathy Ghoneim, Professor 01001215565 ahghoneim@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ahmed M. EL_Minshawy, Professor Assiut University

Publications of Results:

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Responsible Party: Ahmed M. Nasr, Assistant Lecturer Cardiothoracic surgery, Assiut University
ClinicalTrials.gov Identifier: NCT03549052     History of Changes
Other Study ID Numbers: Echo in mitral valve diseases
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Rheumatic Diseases
Ventricular Dysfunction
Rheumatic Heart Disease
Ventricular Dysfunction, Right
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections