Clonidine and Left Ventricular Dysfunction

This study has been withdrawn prior to enrollment.

First Received on September 13, 2005. Last Updated on November 28, 2007 History of Changes

Sponsor:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00213902

Purpose

The objectives of this study are:

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

placebo (n=35) or to
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.

Condition	Phase
Ventricular Dysfunction	Phase II

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Estimated Enrollment:	70
Study Start Date:	April 2004

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213902

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Pascal Bousquet, MD

Hopitaux Universitaires de Strasbourg

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00213902 History of Changes
Other Study ID Numbers:	3153
Study First Received:	September 13, 2005
Last Updated:	November 28, 2007
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Strasbourg, France:

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

Additional relevant MeSH terms:

Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012