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

This study is currently recruiting participants.
Verified February 2017 by Adam Ogna, Centre Hospitalier Universitaire Vaudois
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073305
First Posted: February 27, 2014
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Adam Ogna, Centre Hospitalier Universitaire Vaudois
  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 Adam Ogna, Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Time to first major cardiovascular event [ Time Frame: 3 years ]
    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 ]
  • Time to first non-fatal acute myocardial infarction [ Time Frame: 3 years ]
  • Time to first hospitalization for acute myocardial ischemia [ Time Frame: 3 years ]
  • Time to first acute heart failure [ Time Frame: 3 years ]
  • Time to first non-fatal stroke [ Time Frame: 3 years ]
  • Time to first acute peripheral vascular event [ Time Frame: 3 years ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: November 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 25, 2014
First Posted: February 27, 2014
Last Update Posted: February 2, 2017
Last Verified: February 2017

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

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