Using Beta Blockers to Treat Mitral Regurgitation

Study Overview
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Brief Summary
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The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.

Detailed Description
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The purpose of this study tests 1) whether Toprol xl, a beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation; 2) investigate the effects of chronic mitral regurgitation on left ventricular remodeling, left ventricular function,exercise capacity and clinical symptoms.

Official Title
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Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation

Conditions
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Heart Disease, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Insufficiency

Intervention / Treatment
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* Drug: Beta-blocker therapy (TOPROL-XL® )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of sever primary mitral regurgitation Normal subjects Exclusion Criteria: Left ventricle ejection fraction of <55% pre and post operation Pregnancy or Lactation Secondary mitral regurgitation due to coronary artery disease, cardiomyopathy, uncontrolled hypertension, or severe aortic stenosis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients who are asymptomatic with normal left ventricular systolic function and who agree to be treated medically for severe primary mitral regurgitation with Beta-blocker therapy. Patients may entered into the Arm 2 (surgical treatment) later on when they develop symptoms or enlarged left ventricle or left ventricular dysfunction or wishes to have surgical treatment of severe primary mitral regurgitation. | Drug: Beta-blocker therapy (TOPROL-XL® )<br>* Patients who are asymptomatic with normal left ventricular systolic function and wish to be medically treated for severe primary mitral regurgitation with Beta-blocker.<br>|
| No Intervention: 2<br>Patients will be surgically treated for severe primary mitral regurgitation as a routine clinical care if they want to be treated surgically or develop symptoms or significant adverse left ventricular remodeling or left ventricular dysfunction. | |
| No Intervention: 3<br>Health Control includes the subjects with no remarkable past medical history and not currently taking any medications. Normal subjects will be used for comparison with patients with severe primary mitral regurgitation in term of clinical, echocardiographic and neuro-hormonal findings. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Neurohormonal Measurements | Change is calculated as the value at 6 months minus the value at baseline. The following neurohormones are measured: Brain type Natriuretic Peptide (BNP), tumor necrosis factor- alpha ( TNF- alpha), norepinephrine, epinephrine and plasma renin activity. | Baseline, 6 months | 
| Change in Left Ventricular Ejection Fraction | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess the systolic function. | Baseline, 6 months | 
| Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling | Baseline, 6 months | 
| Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling | Baseline, 6 months | 
| Change on Left Ventricular Mass | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on the Regurgitant Stroke Volume | Measured on Echocardiogram. This will be calculated using the proximal isovelocity surface area (PISA) method.Change is calculated as the value at 6 months minus the value at baseline. | 6 months | 
| Change in Pulmonary Venous Systolic Flow Reversal | Measured on Echocardiogram Color Doppler mapping of Mitral Regurgitation (MR) jets will be used to semiquantitative asses severity of MR using a 4 point scale( 1-4, where higher scores denotes worse outcomes). | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Disease, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Insufficiency, Heart Surgery, Heart Valve Surgery