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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre Hospitalier Universitaire Vaudois
Sponsor:
Information provided by (Responsible Party):
Adam Ogna, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT02073305
First received: February 25, 2014
Last updated: February 27, 2014
Last verified: February 2014

February 25, 2014
February 27, 2014
June 2012
June 2017   (final data collection date for primary outcome measure)
Time to first major cardiovascular event [ Time Frame: 3 years ] [ Designated as safety issue: No ]
composite end-point of all-cause mortality, acute myocardial infarction, hospitalization for acute myocardial ischemia, acute heart failure, stroke, acute peripheral vascular event
Same as current
Complete list of historical versions of study NCT02073305 on ClinicalTrials.gov Archive Site
  • Time to cardiovascular death [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to first non-fatal acute myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to first hospitalization for acute myocardial ischemia [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to first acute heart failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to first non-fatal stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to first acute peripheral vascular event [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
3 Years
Not Provided
Non-Probability Sample

patients with end stage renal disease on renal replacement therapy

  • Obstructive Sleep Apnea
  • End Stage Renal Disease
  • Other: No Sleep Apnea
    No intervention
  • Other: Sleep Apnea - untreated
    No intervention
  • Device: Sleep Apnea - treated
    Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance
  • No sleep apnea
    Subjects with no or light sleep apnea (AHI < 15/h)
    Intervention: Other: No Sleep Apnea
  • 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.

    Intervention: Other: Sleep Apnea - untreated
  • 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.
    Intervention: Device: Sleep Apnea - treated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • unstable congestive heart failure
  • active psychiatric disease
Both
18 Years and older
No
Switzerland
 
NCT02073305
CIRS-SASinHD_003
No
Adam Ogna, Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Not Provided
Principal Investigator: Raphaël Heinzer, MD Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Principal Investigator: Adam Ogna, 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)
Centre Hospitalier Universitaire Vaudois
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP