Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients (SASinHD_003)

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; End Stage Renal Disease
• Intervention / Treatment: Other: No Sleep Apnea; Other: Sleep Apnea - untreated; Device: Sleep Apnea - treated

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with end stage renal disease on renal replacement therapy

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unstable congestive heart failure
• active psychiatric disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No sleep apnea; Subjects with no or light sleep apnea (AHI < 15/h)	Other: No Sleep Apnea; No intervention
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.	Other: Sleep Apnea - untreated; No intervention
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.	Device: Sleep Apnea - treated; Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Raphaël Heinzer, 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)

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; cardiovascular events; end stage renal disease
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Urologic Diseases; Renal Insufficiency; Signs and Symptoms, Respiratory; Renal Insufficiency, Chronic; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Diseases; Apnea; Kidney Failure, Chronic
• Other Study ID Numbers: CIRS-SASinHD_003