Using Beta Blockers to Treat Mitral Regurgitation

Heart Disease Clinical Trial

— REGURG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00700947
• Other study ID #: 2007H0120
• Secondary ID: AHA-0335098N
• Status: Terminated
• Phase: Phase 1
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases
• Heart Valve Disease
• Heart Valve Diseases
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Drug:
• Beta-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.

Locations

Country	Name	City	State
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

Pu M, Gao Z, Li J, Sinoway L, Davidson WR Jr. Development of a new animal model of chronic mitral regurgitation in rats under transesophageal echocardiographic guidance. J Am Soc Echocardiogr. 2005 May;18(5):468-74. — View Citation

Pu M, Gao Z, Pu DK, Davidson WR Jr. Effects of early, late, and long-term nonselective ß-blockade on left ventricular remodeling, function, and survival in chronic organic mitral regurgitation. Circ Heart Fail. 2013 Jul;6(4):756-62. doi: 10.1161/CIRCHEART — View Citation

Pu M, Gao Z, Zhang X, Liao D, Pu DK, Brennan T, Davidson WR Jr. Impact of mitral regurgitation on left ventricular anatomic and molecular remodeling and systolic function: implication for outcome. Am J Physiol Heart Circ Physiol. 2009 Jun;296(6):H1727-32. — View Citation

Pu M. The frequency, impact, and management of mitral regurgitation in patients with heart failure. Curr Cardiol Rep. 2006 May;8(3):226-31. Review. — View Citation

Yang H, Davidson WR Jr, Chambers CE, Pae WE, Sun B, Campbell DB, Pu M. Preoperative pulmonary hypertension is associated with postoperative left ventricular dysfunction in chronic organic mitral regurgitation: an echocardiographic and hemodynamic study. J Am Soc Echocardiogr. 2006 Aug;19(8):1051-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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