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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No sleep apnea | Subjects with no or light sleep apnea (AHI < 15/h) |
| |
| Sleep Apnea - untreated | 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. |
| |
| Sleep Apnea - treated | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Sleep Apnea | Other | No intervention |
| |
| Sleep Apnea - untreated |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients with end stage renal disease on renal replacement therapy
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| Name | Affiliation | Role |
|---|---|---|
| Raphaël Heinzer, MD | Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Principal Investigator |
| Adam Ogna, MD | Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Principal Investigator |
| Valentina Forni Ogna, MD | Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| Other |
No intervention |
|
| Sleep Apnea - treated | Device | Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance |
|
| 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 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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