Clonidine and Left Ventricular Dysfunction
Information source: University Hospital, Strasbourg, France
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ventricular Dysfunction
Phase: Phase 2
Status: Withdrawn
Sponsored by: University Hospital, Strasbourg, France Official(s) and/or principal investigator(s):
Pascal Bousquet, MD, Principal Investigator, Affiliation: Hopitaux Universitaires de Strasbourg
Summary
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.
Clinical Details
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
Study design: Prospective
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age: 60 and greater
- Gender: Both
- Patients with heart failure New York Heart Association (NYHA) II and ejection fraction
over 45%
Locations and Contacts
Additional Information
Starting date: April 2004
Last updated: November 28, 2007
|
