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Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00213902

Enrollment

Registered

2005-09-21

Start date

2004-04-30

Completion date

Unknown

Last updated

2007-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Dysfunction

Keywords

Heart failure, Diastolic, functionClonidine, Left ventricular diastolic dysfunction with preserved ejection fraction

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Outcome results