Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients

Conditions
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Obstructive Sleep Apnea, End Stage Renal Disease

Intervention / Treatment
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* Other: No Sleep Apnea
* Other: Sleep Apnea - untreated
* Device: Sleep Apnea - treated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: end stage renal disease on renal replacement therapy age ≥ 18 years Exclusion Criteria: unstable congestive heart failure active psychiatric disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No sleep apnea<br>Subjects with no or light sleep apnea (AHI < 15/h) | Other: No Sleep Apnea<br>* No intervention<br>|
| Sleep Apnea - untreated<br>Subjects with moderate to severe sleep apnea (AHI ≥15/h) and no specific treatment. Decision to treat or not sleep apnea is left to the treating physician, independently of the study protocol. | Other: Sleep Apnea - untreated<br>* No intervention<br>|
| Sleep Apnea - treated<br>Subjects with treated moderate to severe sleep apnea (AHI ≥15/h). Decision to treat or not sleep apnea is left to the treating physician, independently of the study protocol. | Device: Sleep Apnea - treated<br>* Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first major cardiovascular event | composite end-point of all-cause mortality, acute myocardial infarction, hospitalization for acute myocardial ischemia, acute heart failure, stroke, acute peripheral vascular event | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to first non-fatal stroke |  | 3 years | 
| Time to first acute peripheral vascular event |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, end stage renal disease, cardiovascular events