Using Beta Blockers to Treat Mitral Regurgitation (REGURG)

Wake Forest University (WFU)

Status and phase: Terminated; Phase 1

Conditions: Mitral Valve Insufficiency; Mitral Regurgitation; Heart Disease; Heart Valve Disease

Treatments: Drug: Beta-blocker therapy (TOPROL-XL® )

Study type: Interventional

Funder types: Other

Identifiers

NCT00700947

2007H0120

AHA-0335098N (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

1

Experimental group

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.

Treatment:

Drug: Beta-blocker therapy (TOPROL-XL® )

2

No Intervention group

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.

3

No Intervention group

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.