Heart Failure
Conditions
Keywords
chronic heart failure, rosuvastatin, endothelial function, skeletal muscle
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, 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.
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.
Interventions
DRUGrosuvastatin
Sponsors
AstraZeneca
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammation in the blood and the skeletal muscle | — |
| Vasculogenesis | — |
| Endothelial function of the radial artery | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak oxygen uptake | — |
| Left ventricular function | — |
Countries
Germany
Outcome results
None listed