Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213902
Status:
WITHDRAWN
Last Update Posted:
2007-11-29
First Post:
2005-09-13
Brief Title:
Clonidine and Left Ventricular Dysfunction
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 ratio to
1 placebo n35 or to
2 clonidine n35 in a dose of 0075 mg twice a day for the first 6 weeks followed by uptitration to 0150 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
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 11 ratio to
1 placebo n35 or to
2 clonidine n35 in a dose of 0075 mg twice a day for the first 6 weeks followed by uptitration to 0150 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None