Clonidine and Left Ventricular Dysfunction

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Overall Official(s)
    • Pascal Bousquet, MD, Principal Investigator, Hopitaux Universitaires de Strasbourg

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