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

• Conditions: Obstructive Sleep Apnea; End Stage Renal Disease
• Interventions: Other: Sleep Apnea - untreated; Other: No Sleep Apnea; Device: Sleep Apnea - treated

• Registration Number: NCT02073305
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04
• Primary Completion: 2021-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• end stage renal disease on renal replacement therapy
• age ≥ 18 years

Exclusion Criteria

• unstable congestive heart failure
• active psychiatric disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleep Apnea - untreated	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.
No sleep apnea	No Sleep Apnea	Subjects with no or light sleep apnea (AHI \< 15/h)
Sleep Apnea - treated	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Vaud, Switzerland