Using Beta Blockers to Treat Mitral Regurgitation (REGURG)

August 10, 2018 updated by: Wake Forest University Health Sciences

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest University Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months
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.
Baseline, 6 months
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
Baseline, 6 months
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
Baseline, 6 months
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
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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).
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Min Pu, MD, The Wake Forest University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007H0120
  • AHA-0335098N (Other Identifier: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We currently have no plan to share participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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