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

Obstructive Sleep Apnea Clinical Trial

— SASinHD_003  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02073305
• Other study ID #: CIRS-SASinHD_003
• Status: Active, not recruiting
• Start date: June 2012
• Est. completion date: November 2022

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• end stage renal disease on renal replacement therapy

• age = 18 years

Exclusion Criteria:

• unstable congestive heart failure

• active psychiatric disease

Related Conditions & MeSH terms

• Apnea
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• No Sleep Apnea
No intervention
• Sleep Apnea - untreated
No intervention

Device:
• Sleep Apnea - treated
Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance

Locations

Country	Name	City	State
Switzerland	Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to cardiovascular death		3 years
Secondary	Time to first non-fatal acute myocardial infarction		3 years
Secondary	Time to first hospitalization for acute myocardial ischemia		3 years
Secondary	Time to first acute heart failure		3 years
Secondary	Time to first non-fatal stroke		3 years
Secondary	Time to first acute peripheral vascular event		3 years