Trials Sponsors Conditions Drugs Pricing

Conditions

Heart Disease Heart Valve Disease Mitral Regurgitation Mitral Valve Insufficiency

Keywords

Heart DiseaseMitral RegurgitationHeart Valve DiseaseMitral Valve InsufficiencyHeart SurgeryHeart Valve Surgery

Outcome Measures

Primary Outcomes (5)

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.
Baseline, 6 months
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.
Baseline, 6 months
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

Study Arms (3)

1

EXPERIMENTAL

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® )

2

NO INTERVENTION

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.

3

NO INTERVENTION

Interventions

Beta-blocker therapy (TOPROL-XL® )Drug

Patients who are asymptomatic with normal left ventricular systolic function and wish to be medically treated for severe primary mitral regurgitation with Beta-blocker.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of sever primary mitral regurgitation
Normal subjects

You may not qualify if:

Sponsors & Collaborators

Wake Forest University Health Sciences
Otherlead

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27104, United States

Related Publications (5)

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.
PMID: 16880102BACKGROUND
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.
PMID: 15891757BACKGROUND

MeSH Terms

Conditions

Heart DiseasesMitral Valve InsufficiencyHeart Valve Diseases

Interventions

Adrenergic beta-AntagonistsMetoprolol

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

Min Pu, MD
The Wake Forest University
PRINCIPAL INVESTIGATOR

Enrollment

27 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

June 19, 2008

Study Start

October 2007

Actual (reported)

Primary Completion

Study Stopped

Using Beta Blockers to Treat Mitral Regurgitation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

Data Sharing

Source record

Locations