Clonidine and Left Ventricular Dysfunction

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213902
First received: September 13, 2005
Last updated: November 28, 2007
Last verified: November 2007
  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

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
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, see Learn About Clinical Studies.

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014