End Stage Renal Disease, Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, end stage renal disease, cardiovascular events
Brief summary
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.
Detailed description
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.
Interventions
No intervention
No intervention
Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance
Sponsors
Study design
Eligibility
Inclusion criteria
* end stage renal disease on renal replacement therapy * age ≥ 18 years
Exclusion criteria
* unstable congestive heart failure * active psychiatric disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first major cardiovascular event | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Time to first acute heart failure | 3 years |
| Time to first non-fatal stroke | 3 years |
| Time to first hospitalization for acute myocardial ischemia | 3 years |
| Time to cardiovascular death | 3 years |
| Time to first non-fatal acute myocardial infarction | 3 years |
| Time to first acute peripheral vascular event | 3 years |
Countries
Switzerland