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Using Beta Blockers to Treat Mitral Regurgitation (REGURG)

Primary Purpose

Heart Disease, Mitral Regurgitation, Heart Valve Disease

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Beta-blocker therapy (TOPROL-XL® )
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring Heart Disease, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Insufficiency, Heart Surgery, Heart Valve Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wake Forest University Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

1

2

3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change on Neurohormonal Measurements
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.
Change in Left Ventricular Ejection Fraction
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess the systolic function.
Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
Change on Left Ventricular Mass
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling

Secondary Outcome Measures

Change on the Regurgitant Stroke Volume
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.
Change in Pulmonary Venous Systolic Flow Reversal
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).

Full Information

First Posted
December 26, 2007
Last Updated
August 10, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00700947
Brief Title
Using Beta Blockers to Treat Mitral Regurgitation
Acronym
REGURG
Official Title
Beta-Blockade in Chronic Mitral Regurgitation: Moving From the Laboratory Experiment to Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Funding terminated
Study Start Date
October 2007 (Actual)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Insufficiency
Keywords
Heart Disease, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Insufficiency, Heart Surgery, Heart Valve Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Arm Title
3
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Beta-blocker therapy (TOPROL-XL® )
Intervention Description
Patients who are asymptomatic with normal left ventricular systolic function and wish to be medically treated for severe primary mitral regurgitation with Beta-blocker.
Primary Outcome Measure Information:
Title
Change on Neurohormonal Measurements
Description
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.
Time Frame
Baseline, 6 months
Title
Change in Left Ventricular Ejection Fraction
Description
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess the systolic function.
Time Frame
Baseline, 6 months
Title
Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic dimensions
Description
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
Time Frame
Baseline, 6 months
Title
Change on Left Ventricle end- Diastolic (LVEDD) and end-Systolic Volumes
Description
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
Time Frame
Baseline, 6 months
Title
Change on Left Ventricular Mass
Description
Measured on Echocardiogram. Change is calculated as the value at 6 months minus the value at baseline. Assess Left ventricular remodeling
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change on the Regurgitant Stroke Volume
Description
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.
Time Frame
6 months
Title
Change in Pulmonary Venous Systolic Flow Reversal
Description
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).
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Pu, MD
Organizational Affiliation
The Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We currently have no plan to share participant data.
Citations:
PubMed Identifier
16880102
Citation
Yang H, Davidson WR Jr, Chambers CE, Pae WE, Sun B, Campbell DB, Pu M. Preoperative pulmonary hypertension is associated with postoperative left ventricular dysfunction in chronic organic mitral regurgitation: an echocardiographic and hemodynamic study. J Am Soc Echocardiogr. 2006 Aug;19(8):1051-5. doi: 10.1016/j.echo.2006.03.016.
Results Reference
background
PubMed Identifier
15891757
Citation
Pu M, Gao Z, Li J, Sinoway L, Davidson WR Jr. Development of a new animal model of chronic mitral regurgitation in rats under transesophageal echocardiographic guidance. J Am Soc Echocardiogr. 2005 May;18(5):468-74. doi: 10.1016/j.echo.2004.10.005.
Results Reference
background
PubMed Identifier
23580745
Citation
Pu M, Gao Z, Pu DK, Davidson WR Jr. Effects of early, late, and long-term nonselective beta-blockade on left ventricular remodeling, function, and survival in chronic organic mitral regurgitation. Circ Heart Fail. 2013 Jul;6(4):756-62. doi: 10.1161/CIRCHEARTFAILURE.112.000196. Epub 2013 Apr 11.
Results Reference
result
PubMed Identifier
19329766
Citation
Pu M, Gao Z, Zhang X, Liao D, Pu DK, Brennan T, Davidson WR Jr. Impact of mitral regurgitation on left ventricular anatomic and molecular remodeling and systolic function: implication for outcome. Am J Physiol Heart Circ Physiol. 2009 Jun;296(6):H1727-32. doi: 10.1152/ajpheart.00882.2008. Epub 2009 Mar 27.
Results Reference
result
PubMed Identifier
17543250
Citation
Pu M. The frequency, impact, and management of mitral regurgitation in patients with heart failure. Curr Cardiol Rep. 2006 May;8(3):226-31. doi: 10.1007/s11886-006-0038-6.
Results Reference
result

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Using Beta Blockers to Treat Mitral Regurgitation

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