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Using Beta Blockers to Treat Mitral Regurgitation (REGURG)

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ClinicalTrials.gov Identifier: NCT00700947
Recruitment Status : Terminated (Funding terminated)
First Posted : June 19, 2008
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Heart Disease Mitral Regurgitation Heart Valve Disease Mitral Valve Insufficiency Drug: Beta-blocker therapy (TOPROL-XL® ) 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation
Actual Study Start Date : October 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Change on Neurohormonal Measurements [ Time Frame: 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.

  2. Change in Left Ventricular Ejection Fraction [ Time Frame: Baseline, 6 months ]
    Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess the systolic function.

  3. Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions [ Time Frame: Baseline, 6 months ]
    Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling

  4. Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes [ Time Frame: Baseline, 6 months ]
    Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling

  5. Change on Left Ventricular Mass [ Time Frame: 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 :
  1. Change on the Regurgitant Stroke Volume [ Time Frame: 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.

  2. Change in Pulmonary Venous Systolic Flow Reversal [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of sever primary mitral regurgitation
  • Normal subjects

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700947


Locations
United States, North Carolina
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

Publications of Results:
Other Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00700947     History of Changes
Other Study ID Numbers: 2007H0120
AHA-0335098N ( Other Identifier: American Heart Association )
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We currently have no plan to share participant data.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Heart Disease
Mitral Regurgitation
Heart Valve Disease
Mitral Valve Insufficiency
Heart Surgery
Heart Valve Surgery

Additional relevant MeSH terms:
Heart Diseases
Mitral Valve Insufficiency
Heart Valve Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Metoprolol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists