Clonidine and Left Ventricular Dysfunction

Withdrawn

• Conditions: Ventricular Dysfunction

• Registration Number: NCT00213902
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

The objectives of this study are:

1. To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF).

2. To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF.

The study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized in a 1:1 ratio to:

1. placebo (n=35) or to

2. clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months.

The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (MRI) and echocardiography.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-28
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age: 60 and greater
• Gender: Both
• Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified