Clonidine and Left Ventricular Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Dysfunction

Keywords

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

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pascal Bousquet, MD

Role: PRINCIPAL_INVESTIGATOR

Hopitaux Universitaires de Strasbourg

Countries

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France

Other Identifiers

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3153

Identifier Type: -

Identifier Source: org_study_id