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Using Beta Blockers to Treat Mitral Regurgitation (REGURG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Ohio State University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00700947
First received: December 26, 2007
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention
Heart Disease
Mitral Regurgitation
Heart Valve Disease
Mitral Valve Insufficiency
 Drug: Beta-blocker therapy (TOPROL-XL® )

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: October 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients who have may or may not of been surgically treated for mitral regurgitation that start Beta-Blocker therapy.
 Drug: Beta-blocker therapy (TOPROL-XL® )
Patients who have 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700947

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Min Pu, MD Ohio State University
  More Information

No publications provided

Responsible Party: Min Pu, MD, PhD, The Ohio State University
ClinicalTrials.gov Identifier: NCT00700947     History of Changes
Other Study ID Numbers: 2007H0120, AHA-0335098N
Study First Received: December 26, 2007
Last Updated: October 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Heart Disease
Mitral Regurgitation
Heart Valve Disease
 Mitral Valve Insufficiency
Heart Surgery
Heart Valve Surgery

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency
Cardiovascular Diseases
Adrenergic beta-Antagonists
Metoprolol succinate
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013