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
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
End Stage Renal Disease
Other: No Sleep Apnea
Other: Sleep Apnea - untreated
Device: Sleep Apnea - treated

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with end stage renal disease on renal replacement therapy

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unstable congestive heart failure
  • active psychiatric disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073305

Locations
Switzerland
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Raphaël Heinzer, MD    +41 21 314 67 48    raphael.heinzer@chuv.ch   
Contact: Adam Ogna, MD    +41 21 314 67 48    adam.ogna@chuv.ch   
Principal Investigator: Adam Ogna, MD         
Principal Investigator: Valentina Forni Ogna, MD         
Principal Investigator: Raphaël Heinzer, MD         
Sponsors and Collaborators
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: 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)
  More Information

No publications provided

Responsible Party: Adam Ogna, Centre d'Investigation et Recherche sur le Sommeil (CIRS), Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02073305     History of Changes
Other Study ID Numbers: CIRS-SASinHD_003
Study First Received: February 25, 2014
Last Updated: February 27, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
obstructive sleep apnea
end stage renal disease
cardiovascular events

Additional relevant MeSH terms:
Apnea
Kidney Diseases
Kidney Failure, Chronic
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014