NCT00213902

Clonidine and Left Ventricular Dysfunction

Evaluation of Effects of Central Sympathetic Inhibition in Elderly With Left Ventricular Diastolic Dysfunction and Preserved Ejection Fraction: A Proof-of-Concept Trial With Clonidine

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Dysfunction

Timeline

• Start date: 2004-04-01
• First posted: 2005-09-21
• Last updated: 2007-11-29