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Clonidine and Left Ventricular Dysfunction

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213902
First Posted: September 21, 2005
Last Update Posted: November 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Strasbourg, France
  Purpose

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.


Condition Phase
Ventricular Dysfunction Phase 2

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:


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

Estimated Enrollment: 70
Study Start Date: April 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213902


Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pascal Bousquet, MD Hopitaux Universitaires de Strasbourg
  More Information

ClinicalTrials.gov Identifier: NCT00213902     History of Changes
Other Study ID Numbers: 3153
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: November 29, 2007
Last Verified: November 2007

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
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action