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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Inflammation in the blood and the skeletal muscle
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Inflammation in the blood and the skeletal muscle
Vasculogenesis
Endothelial function of the radial artery
次要结局
- Left ventricular function
- Peak oxygen uptake