Clonidine and Left Ventricular Dysfunction

University Hospital, Strasbourg, France

Status: Withdrawn

Conditions: Ventricular Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT00213902

3153

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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