Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
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, e.g. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|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|
- Inflammation in the blood and the skeletal muscle
- Endothelial function of the radial artery
- Peak oxygen uptake
- Left ventricular function
|Study Start Date:||March 2004|
|Study Completion Date:||December 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176332
|University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology|
|Leipzig, Saxony, Germany, 04289|
|Principal Investigator:||Rainer P Hambrecht, MD||University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology|