Ventricular Dysfunction Clinical Trial
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
NCT number | NCT00213902 |
Other study ID # | 3153 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | September 13, 2005 |
Last updated | November 28, 2007 |
Start date | April 2004 |
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.
Status | Withdrawn |
Enrollment | 70 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Age: 60 and greater - Gender: Both - Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45% |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
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