Clinical trial NCT02073305: Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients
Official title: Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
End Stage Renal Disease
Keywords: obstructive sleep apnea
end stage renal disease
cardiovascular events
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with end stage renal disease on renal replacement therapy

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* unstable congestive heart failure
* active psychiatric disease

Primary outcomes:
measure: Time to first major cardiovascular event
timeFrame: 3 years
Secondary outcomes:
measure: Time to cardiovascular death
timeFrame: 3 years
measure: Time to first non-fatal acute myocardial infarction
timeFrame: 3 years
measure: Time to first hospitalization for acute myocardial ischemia
timeFrame: 3 years
measure: Time to first acute heart failure
timeFrame: 3 years
measure: Time to first non-fatal stroke
timeFrame: 3 years
measure: Time to first acute peripheral vascular event
timeFrame: 3 years
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Raphaël Heinzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Adam Ogna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
name: Valentina Forni Ogna, MD
role: PRINCIPAL_INVESTIGATOR
References: