Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to first major cardiovascular event
研究概览
简要总结
The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.
详细描述
Sleep apnea is more prevalent in end stage renal disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea in the general population, the prognostic impact of sleep apnea in the end stage renal disease population has not yet been investigated.
The purpose of this trial is to investigate the hypothesis that moderate to severe sleep apnea increase the risk of major cardiovascular events in patients with end stage renal disease.
The severity of sleep apnea is measured at inclusion and the patients are followed during 3 years to assess the cardiovascular end-points. The result of the sleep study is communicated to the treating physician and the decision whether to treat or not sleep apnea is left to the treating physician, independently of the study protocol. The comparison will include three groups: patients without sleep apnea, untreated patients with moderate to severe sleep apnea and treated patients with sleep apnea.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •end stage renal disease on renal replacement therapy
- •age ≥ 18 years
排除标准
- •unstable congestive heart failure
- •active psychiatric disease
结局指标
主要结局
Time to first major cardiovascular event
时间窗: 3 years
composite end-point of all-cause mortality, acute myocardial infarction, hospitalization for acute myocardial ischemia, acute heart failure, stroke, acute peripheral vascular event
次要结局
- Time to first non-fatal stroke(3 years)
- Time to first acute peripheral vascular event(3 years)
- Time to cardiovascular death(3 years)
- Time to first non-fatal acute myocardial infarction(3 years)
- Time to first hospitalization for acute myocardial ischemia(3 years)
- Time to first acute heart failure(3 years)
研究者
Adam Ogna
Centre d'Investigation et Recherche sur le Sommeil (CIRS)
Centre Hospitalier Universitaire Vaudois