Exercise Versus Extended-Release Niacin in Patients With Coronary Heart Disease and Low High-Density Lipoproteins (HDL) Cholesterol: Effect on Lipid Profile and Endothelial Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- relative effect on flow-mediated dilatation of radial artery
研究概览
简要总结
The investigators want to study the relative effects of physical exercise vs. extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low HDL cholesterol ("good cholesterol") on
- lipid profile
- endothelial function as measured by ultrasound
The endothelium is the inner part of the blood vessels. Impaired endothelial function is known to be associated with atherosclerosis which can ultimately lead to diseases such as stroke, heart attack and others. Endothelial function can be assessed non-invasively by ultrasound.
Both interventions mentioned above have been shown to have a beneficial effect on lipid profile and endothelial function. However, the relative effects are unclear.
详细描述
Comparison of physical exercise vs. extended-release niacin in patients with CAD and low HDL cholesterol (< 1,03 mmol/L) on lipid profile and endothelial function as measured by flow-mediated dilatation of radial artery. Secondary goals are the assessment of biochemical markers of atherosclerosis, expression of monocyte surface markers, oxidative stress and thrombogenicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary disease
- •Low HDL cholesterol
- •Age limits (see below)
排除标准
- •Unstable angina oder MI within 3 months prior to inclusion
- •CAD with indication for bypass surgery
- •Left main disease ( > 25% stenosis diameter)
- •Ejection fraction < 40%
- •Higher degree heart valve disease
- •Higher degree ventricular arrhythmias
- •Type 1 Diabetes
- •Severe disorders of lipoprotein metabolism (Low-density lipoprotein cholesterol (LDL)> 5.0 mmol/L)
- •Severe liver disease
- •Thyroid disease
- •Alcohol or drug abuse
- •Pregnancy
- •Stroke or Transient Ischemic Attack (TIA) within 3 months prior to inclusion
- •Allergy against niacin oder other ingredient of niaspan
- •Participation in other clinical trial within 30 days prior to inclusion
- •Acute gastric ulcer
- •Arterial bleeding
- •Uncontrolled severe arterial hypertension
- •Treatment with lipid-lowering drug other than Hydroxy-Methylglutaryl Coenzyme A (HMG-CoA)-inhibitor within 3 months prior to inclusion
研究组 & 干预措施
1
niacin
干预措施: niaspan (extended-release niacin) (Drug)
1
niacin
干预措施: niacin (Drug)
2
physical exercise
干预措施: physical exercise (Behavioral)
3
control
干预措施: control (Other)
结局指标
主要结局
relative effect on flow-mediated dilatation of radial artery
时间窗: 6 months
次要结局
- lipid profile(6 months)
- biochemical markers of atherosclerosis(6 months)
- expression of monocyte surface markers(6 months)
- oxidative stress(6 months)
- thrombogenicity(6 months)
研究者
Steffen Desch, MD
Priv.-Doz. Dr. med.
University of Leipzig