Overview

This trial is active, not recruiting.

Conditions heart disease, mitral regurgitation, heart valve disease, mitral valve insufficiency
Treatment beta-blocker therapy (toprol-xl® )
Sponsor Ohio State University
Start date October 2007
End date December 2009
Trial size 66 participants
Trial identifier NCT00700947, 2007H0120, AHA-0335098N

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients who have may or may not of been surgically treated for mitral regurgitation that start Beta-Blocker therapy.
beta-blocker therapy (toprol-xl® )
Patients who have been surgically treated for mitral regurgitation that start Beta-Blocker therapy.
(No Intervention)
Patients who have been surgically treated for mitral regurgitation.
(No Intervention)
Health Control with no remarkable past medical history and not currently taking any medications.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Test new noninvasive methods to assess global and regional myocardial contractility in chronic MR, correlating the results with biochemical markers.
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation
Principal investigator Min Pu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Ohio State University.