Protective Effect of Statin on Arrhythmia and Heart Rate Variability in Healthy People With 48 Hours of Sleep Deprivation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- a change in low-frequency (LF)/ high frequency (HF)
研究概览
简要总结
This study aimed to investigate the effect of 48-h sleep deprivation on heart rate variability (HRV) in young healthy people and the protective effect of statin on arrhythmia and HRV.
详细描述
In the setting of earthquakes, floods, or fire disasters, rescue workers usually carry out their work without sleep. Sleep deprivation (SD), which is a strong stressor, can exert a large effect on the cardiovascular system of rescue workers. It has been reported that SD is associated with arrhythmia, dyslipidemia and type 2 diabetes. Heart rate variability (HRV) is acknowledged as a reliable marker of cardiac autonomic control, and the frequency of premature ventricular complexes can be an indicator of arrhythmogeneity. The investigators found that HRV was significantly decreased after 24-h sleep deprivation. Metoprolol could improve HRV and reduce the frequency of premature atrial and ventricular complexes. But sleepiness and hypotension occurred frequently in subjects treated with metoprolol. Statins have significant cardiovascular protective effects in patients with cardiovascular disease. Statin not only could regulate serum lipid level, but also have antioxidant and anti-inflammatory properties. This study aimed to investigate (1) the changes in heart rate variability and occurrence of cardiac arrhythmia by continuous ambulatory electrocardiogram (ECG) in young, healthy subjects undergoing 48h SD and (2) the effects of statin on HRV and arrhythmia after this agent was administered prophylactically before SD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects without cardiovascular disease
排除标准
- •hypertension
- •diabetes mellitus
- •hyperthyroidism
- •taking medication known to affect cardiovascular, metabolic, gastrointestinal, or immune function
- •depression
- •anxiety disorders
研究组 & 干预措施
Statin group
drug: atorvastatin (Pfizer, U.S.); the frequency: 20mg atorvastatin was taken daily; duration: Study treatment was commenced 3 days before sleep deprivation and continued for 2 days during sleep deprivation.
干预措施: Atorvastatin (Drug)
Control group
drug: placebo (Pfizer, U.S.); the frequency: Placebo was taken daily; duration: Study treatment was commenced 3 days before sleep deprivation and continued for 2 days during sleep deprivation.
干预措施: placebo (Drug)
结局指标
主要结局
a change in low-frequency (LF)/ high frequency (HF)
时间窗: 48-h sleep deprivation
The primary efficacy endpoint was the effect of statin on LF/HF measured by continuous ambulatory electrocardiogram monitoring after 48-h sleep deprivation.
次要结局
- a change in the frequency of premature atrial and ventricular complexes(48-h sleep deprivation)
- a change in serum superoxide dismutase level(48-h sleep deprivation)
- a change in serum high sensitivity C-reactive protein level(48-h sleep deprivation)
- a change in serum total cholesterol level(48-h sleep deprivation)
研究者
Shi Yang
Professor
Chinese PLA General Hospital
