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Clonidine and Left Ventricular Dysfunction

This study has been withdrawn prior to enrollment.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

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

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

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
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Please refer to this study by its identifier: NCT00213902

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

No publications provided 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
Left ventricular diastolic dysfunction with preserved ejection fraction

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases processed this record on November 20, 2014