PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function
NCT ID: NCT01900379
Last Updated: 2017-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2013-07-31
2016-09-30
Brief Summary
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Detailed Description
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The first objective is to evaluate the influence of continuous positive airway pressure (CPAP) treatment for OSAS on the ventricular function improvement in heart failure patients, in comparison with OSA patients treated with sham CPAP. This treatment will be instaurated just after the coronary reperfusion surgery
Secondary objectives :
* Evaluation of the effect of CPAP treatment on the endothelial function
* Evaluation of the effect of CPAP treatment on systemic inflammation
* Evaluation of the effect of CPAP treatment on oxidative stress,
* Evaluation of the effect of CPAP treatment on insulin resistance,
after the coronary reperfusion surgery, in comparison with OSA patients treated with sham CPAP and non apneic control patients, with heart failure.
* Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected during surgery.
* Assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity on abdominal and epicardiac adipose tissue collected during surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OSA/CPAP
OSA patients intervention : CPAP treatment
CPAP treatment
This device consists in a nasal continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/CPAP patients group.
OSA/sham CPAP
OSA patients intervention : Sham CPAP treatment
Sham CPAP treatment
This device consists in a sham continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/sham CPAP patients group.
control group
Patients without any apnea syndrome
No interventions assigned to this group
Interventions
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CPAP treatment
This device consists in a nasal continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/CPAP patients group.
Sham CPAP treatment
This device consists in a sham continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/sham CPAP patients group.
Eligibility Criteria
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Inclusion Criteria
* Heart failure patient: with altered left ventricular ejection fraction by ultrasonography (≤ 50% in 2D) or in 3D
Exclusion Criteria
* Aortic surgery
* Triple stimulator implanted less than 6 months ago
* Patient already treated for a SAOS syndrome
* Patient with a central sleep apnea syndrome
* Patient with malignant evolutive pathology
* Pregnant or lactating women
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Renaud TAMISIER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Grenoble, France
Locations
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University Hospital of Grenoble
Grenoble, , France
Countries
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Other Identifiers
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2013-A00543-42
Identifier Type: OTHER
Identifier Source: secondary_id
1310
Identifier Type: -
Identifier Source: org_study_id
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