- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213902
Clonidine and Left Ventricular Dysfunction
November 28, 2007 updated by: University Hospital, Strasbourg, France
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
The objectives of this study are:
- To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF).
- 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:
- placebo (n=35) or to
- 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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Enrollment (Anticipated)
70
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 60 and greater
- Gender: Both
- Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pascal Bousquet, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
November 29, 2007
Last Update Submitted That Met QC Criteria
November 28, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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