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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

The purpose of this study tests whether Toprol xl, a beta-blocker drug, will benefit patients with chronic mitral regurgitation after mitral valve surgery and to investigation effects of chronic mitral regurgitation on heart size, heart function, exercise capacity and clinical symptoms.

Intervention(s) in this Clinical Trial

• Drug: Beta-blocker therapy (TOPROL-XL® )
  • Patients who have been surgically treated for mitral regurgitation that start Beta-Blocker therapy.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients who have may or may not of been surgically treated for mitral regurgitation that start Beta-Blocker therapy.
• No Intervention: 2
  • Patients who have been surgically treated for mitral regurgitation.
• No Intervention: 3
  • Health Control with no remarkable past medical history and not currently taking any medications.

Primary Measures

• Assess the impact of chronic mitral regurgitation (MR) on neurohormonal activation, left ventricular remodeling, function and reserve in patients with or without surgery. Determine the effect of beta-blockade previously mentioned markers of MR.
  • Time Frame: 6 months
    Safety Issue?: Yes

Secondary Measures

• Test new noninvasive methods to assess global and regional myocardial contractility in chronic MR, correlating the results with biochemical markers.
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• diagnosis of Mitral Regurgitation

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Ohio State University

Overall Clinical Trial Officials and Contacts

Min Pu, MD Principal Investigator Ohio State University  

Overall Contact: Leah Sanuk, RN 614-292-6789 Leah.Sanuk@osumc.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700947

Study ID Number: 2007H0120

ClinicalTrials.gov Identifier: NCT00700947

Health Authority: United States: Institutional Review Board