Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176332
Status:
COMPLETED
Last Update Posted:
2007-08-01
First Post:
2005-09-10
Brief Title:
Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
Sponsor:
University of Leipzig
Organization:
University of Leipzig
Study Overview
Official Title:
Impact of Three Months of Rosuvastatin Treatment on Peripheral Endothelial Function Inflammatory Markers in the Blood and the Skeletal Muscle and on Postnatal Vasculogenesis in Patients With Severe Chronic Heart Failure
Status:
COMPLETED
Status Verified Date:
2007-07
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:
Statin therapy has been shown to efficiently reduce mortality in patients with coronary artery disease and myocardial infarction partially as a result of the lipid-lowering properties of statins However especially the pleiotropic effects of statins eg their anti-inflammatory and anti-oxidative properties might be of interest in the treatment of patients with chronic heart failure that are limited in their exercise capacity due to alterations of the skeletal muscle and peripheral endothelial dysfunction
Aim of this trial is therefore to assess the effects of three months of rosuvastatin treatment on markers of inflammation and oxidative stress in the skeletal muscle and the blood on postnatal vasculogenesis and endothelial function of the radial artery in patients with severe chronic heart failure
Aim of this trial is therefore to assess the effects of three months of rosuvastatin treatment on markers of inflammation and oxidative stress in the skeletal muscle and the blood on postnatal vasculogenesis and endothelial function of the radial artery in patients with severe chronic heart failure
Detailed Description:
A total of 40 patients with severe chronic heart failure are prospectively randomized to either 3 months of rosuvastatin or placebo treatment
Before and after the intervention period maximal exercise capacity is measured by ergospirometry and endothelial function is determined by high-resolution A-mode ultrasound Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for inflammatory markers measures of oxidative stress and vasculogenesis Blood samples are assessed with regard to markers of inflammation and oxidative stress as well
Before and after the intervention period maximal exercise capacity is measured by ergospirometry and endothelial function is determined by high-resolution A-mode ultrasound Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for inflammatory markers measures of oxidative stress and vasculogenesis Blood samples are assessed with regard to markers of inflammation and oxidative stress as well
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