Using Beta Blockers to Treat Mitral Regurgitation - Full Text View

Sponsor:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00700947

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:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases Heart Valve Diseases Surgery

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
1: Experimental 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.
2: No Intervention Patients who have been surgically treated for mitral regurgitation.
3: No Intervention 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:	The Ohio State University ( Min Pu, MD, PhD )
Study ID Numbers:	2007H0120, AHA-0335098N
Study First Received:	December 26, 2007
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00700947 History of Changes
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:

Neurotransmitter Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists

Adrenergic Antagonists
Cardiovascular Diseases
Pharmacologic Actions
Mitral Valve Insufficiency
Heart Valve Diseases

ClinicalTrials.gov processed this record on February 09, 2010