Heart Disease, Heart Valve Disease, Mitral Regurgitation, Mitral Valve Insufficiency
Conditions
Keywords
Heart Disease, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Insufficiency, Heart Surgery, Heart Valve Surgery
Brief summary
The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.
Detailed description
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.
Interventions
DRUGBeta-blocker therapy (TOPROL-XL® )
Patients who are asymptomatic with normal left ventricular systolic function and wish to be medically treated for severe primary mitral regurgitation with Beta-blocker.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction | Baseline, 6 months | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess the systolic function. |
| Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes | Baseline, 6 months | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling |
| Change on Left Ventricular Mass | Baseline, 6 months | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling |
| Change on Neurohormonal Measurements | Baseline, 6 months | 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. |
| Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions | Baseline, 6 months | Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Venous Systolic Flow Reversal | Baseline, 6 months | 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). |
| Change on the Regurgitant Stroke Volume | 6 months | 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. |
Countries
United States
Outcome results
None listed