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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00700947
Other study ID # 2007H0120
Secondary ID AHA-0335098N
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
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