REGURG: Using Beta Blockers to Treat Mitral Regurgitation
Study Details
Study Description
Brief Summary
The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 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. |
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.
|
| No Intervention: 2 Patients will be surgically treated for severe primary mitral regurgitation as a routine clinical care if they want to be treated surgically or develop symptoms or significant adverse left ventricular remodeling or left ventricular dysfunction. |
|
| No Intervention: 3 Health Control includes the subjects with no remarkable past medical history and not currently taking any medications. Normal subjects will be used for comparison with patients with severe primary mitral regurgitation in term of clinical, echocardiographic and neuro-hormonal findings. |
Outcome Measures
Primary Outcome Measures
- 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 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 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
Secondary Outcome Measures
- 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.
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of sever primary mitral regurgitation
-
Normal subjects
Exclusion Criteria:
-
Left ventricle ejection fraction of <55% pre and post operation
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Pregnancy or Lactation
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Secondary mitral regurgitation due to coronary artery disease, cardiomyopathy, uncontrolled hypertension, or severe aortic stenosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27104 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Min Pu, MD, The Wake Forest University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 2007H0120
- AHA-0335098N