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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02073305
Acronym
SASinHD_003
Enrollment
200
Registered
2014-02-27
Start date
2012-06-30
Completion date
2022-11-30
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Obstructive Sleep Apnea

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

OTHERNo Sleep Apnea

No intervention

OTHERSleep Apnea - untreated

No intervention

DEVICESleep Apnea - treated

Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Time to first major cardiovascular event3 yearscomposite end-point of all-cause mortality, acute myocardial infarction, hospitalization for acute myocardial ischemia, acute heart failure, stroke, acute peripheral vascular event

Secondary

MeasureTime frame
Time to first acute heart failure3 years
Time to first non-fatal stroke3 years
Time to first hospitalization for acute myocardial ischemia3 years
Time to cardiovascular death3 years
Time to first non-fatal acute myocardial infarction3 years
Time to first acute peripheral vascular event3 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026