Clinical trial NCT00176332: Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: chronic heart failure
rosuvastatin
endothelial function
skeletal muscle
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Inflammation in the blood and the skeletal muscle
measure: Vasculogenesis
measure: Endothelial function of the radial artery
Secondary outcomes:
measure: Peak oxygen uptake
measure: Left ventricular function
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
state: Saxony
Study officials:
affiliation: University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
name: Rainer P Hambrecht, MD
role: PRINCIPAL_INVESTIGATOR
References: