Effects of Atorvastatin on Endothelial Function, Vascular and Myocardial Redox State in High Cardiovascular Risk Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Vascular Nitric oxide bioavailability (Arm A + B)
研究概览
简要总结
The present study constitutes a study examining the effect of atorvastatin on vascular function in high cardiovascular risk patients. For this purpose the investigators will record atorvastatin effects on statin-naïve patients (patients that start statins treatment for first time). More specifically the investigators will study atorvastatin effects on:
- Endothelial function
- Arterial elastic properties
- Systemic Inflammatory/thrombotic mechanisms
- Vascular and myocardial redox state
详细描述
In total we will recruit 72 high cardiovascular risk patients such as patients with ischemic cardiomyopathy (ischemic heart failure), coronary artery disease and/or patients undergoing elective coronary bypass artery grafting (CABG), valve replacement or aortic surgery. The whole study will be divided into 2 distinct clinical arms:
ARM A
In this arm patients with ischemic heart failure (NYHA II-III) will be recruited. In a double-blind crossover design heart failure patients (n=30) naïve to statins treatment will be randomized to atorvastatin 10mg/day (n=15) or 40mg/day (n=15) for 4 weeks. At the end of 4 weeks a 2-week wash out period will follow and then all patients will switch atorvastatin dose (e.g all patients that were under atorvastatin 10mg/day will be switched to 40mg/day and vice versa).
Both at baseline and at the end of 4 weeks period patients will undergo
- blood sampling
- assessment of endothelium-dependent and -independent vasodilatation and
- vascular elastic properties study (see below for methods).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease confirmed by coronary angiography.
- •Patients undergoing cardiac surgery such as elective coronary bypass artery grafting (CABG), valve replacement or aortic surgery.
- •All patients will not be under statins treatment for at least 6 months before their inclusion to the study.
排除标准
- •Acute coronary syndrome during the last 2 months
- •Renal failure (creatinine > 2,2 mg/dl)
- •Severe liver disease. Prospective follow-up of liver enzymes will be performed by the physicians in charge, as indicated by the relative guidelines regarding statins use and according to the current clinical practice.
- •Any chronic/acute inflammatory disease, autoimmune disease and/or cancer
- •Use of anti-inflammatory drugs or vitamins supplements
研究组 & 干预措施
Atorvastatin, Ischemic Heart Disease
干预措施: Atorvastatin, high vs low dose (Drug)
Atorvastatin vs Placebo Cardiac Surgery
干预措施: Atorvastatin vs Placebo (Drug)
结局指标
主要结局
Vascular Nitric oxide bioavailability (Arm A + B)
时间窗: At the start and at the end of 2-week treatment period (arm A) and at the start and at the end of 3-day treatment period (arm B)
次要结局
- Vascular Redox state (Arm B)(At the end of 3-day treatment period)
- Myocardial redox state (Arm B)(At the end of 3-day treatment period)
- Systemic inflammatory, thrombotic and oxidative stress status (Arms A + B)(At the start and at the end of 2-week treatment period (arm A) and at the start and at the end of 3-day treatment period (arm B))
- Vascular elastic properties (Arm A)(At the start and at the end of 2-week treatment period)
研究者
Dimitris Tousoulis
Professor of Cardiology
Hippocration General Hospital