Clinical trial NCT00700947: Using Beta Blockers to Treat Mitral Regurgitation
Official title: Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Heart Disease
Mitral Regurgitation
Heart Valve Disease
Mitral Valve Insufficiency
Keywords: Heart Disease
Mitral Regurgitation
Heart Valve Disease
Mitral Valve Insufficiency
Heart Surgery
Heart Valve Surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change on Neurohormonal Measurements
timeFrame: Baseline, 6 months
measure: Change in Left Ventricular Ejection Fraction
timeFrame: Baseline, 6 months
measure: Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions
timeFrame: Baseline, 6 months
measure: Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes
timeFrame: Baseline, 6 months
measure: Change on Left Ventricular Mass
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change on the Regurgitant Stroke Volume
timeFrame: 6 months
measure: Change in Pulmonary Venous Systolic Flow Reversal
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: The Wake Forest University
name: Min Pu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.echo.2006.03.016.
citation: 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. doi: 10.1016/j.echo.2004.10.005.
citation: Pu M, Gao Z, Pu DK, Davidson WR Jr. Effects of early, late, and long-term nonselective beta-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/CIRCHEARTFAILURE.112.000196. Epub 2013 Apr 11.
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. doi: 10.1152/ajpheart.00882.2008. Epub 2009 Mar 27.
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. doi: 10.1007/s11886-006-0038-6.