Using Beta Blockers to Treat Mitral Regurgitation

Phase 1

Terminated

• Conditions: Mitral Regurgitation; Heart Valve Disease; Mitral Valve Insufficiency; Heart Disease
• Interventions: Drug: Beta-blocker therapy (TOPROL-XL® )

• Registration Number: NCT00700947
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Beta-blocker therapy (TOPROL-XL® )	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.

Primary Outcome Measures

Name	Time	Method
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 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
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 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 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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States