Overview

Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
All
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, 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Leipzig
Collaborator:
AstraZeneca
Treatments:
Rosuvastatin Calcium
Criteria
Inclusion Criteria:

- chronic heart failure (NYHA class III or IV)

- peak oxygen uptake <20 mL/min/kg body weight

- left ventricular ejection fraction <30 %

- left ventricular end-diastolic diameter >55 mm

- stable medication within the last 4 weeks

Exclusion Criteria:

- elevated GOT and GPT levels as a sign of hepatic dysfunction

- elevated creatinine levels as a sign of renal dysfunction

- insulin-dependent diabetes mellitus

- arterial hypertension

- muscle disease or elevated CK levels

- treatment with fibrates

- co-treatment with drugs that are metabolized by Cyp3A4

- diseases that disallow a participation in the study