PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function
NCT ID: NCT01741337
Last Updated: 2017-02-02
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
10 participants
INTERVENTIONAL
2013-01-29
2015-05-31
Brief Summary
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Detailed Description
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The first objective is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient, in terms of ventricular recovery (ejection fraction improvement). This treatment will be instaurated just after coronary artery bypass graft surgery or other coronary reperfusion.
Secondary objectives :
* Assessment of adaptive servo-ventilation effect on the endothelial function, the systemic inflammation and oxidative stress, the insulin resistance, after the surgery in comparison with non treated patient with heart failure and central sleep apneas.
* Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected only during coronary artery bypass graft 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
NONE
Study Groups
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Patients treated by ventilation
Adaptive servo-ventilation post-operative treatment for 6 months
Adaptive servo-ventilation post-operative treatment for 6 months
Patients not treated by ventilation
Patients not treated during 6 months by an adaptive servo-ventilation
No interventions assigned to this group
Interventions
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Adaptive servo-ventilation post-operative treatment for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* heart failure patient: with altered left ventricular ejection fraction by ultrasonography (45%\< LVEF ≤ 50% in 2D) or in 3D
* Patient with central sleep apneas syndrome (SAS)
Exclusion Criteria
* Patient already treated for a central SAS
* Patient with an obstructive SAS
* 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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References
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Vazir A, Hastings PC, Dayer M, McIntyre HF, Henein MY, Poole-Wilson PA, Cowie MR, Morrell MJ, Simonds AK. A high prevalence of sleep disordered breathing in men with mild symptomatic chronic heart failure due to left ventricular systolic dysfunction. Eur J Heart Fail. 2007 Mar;9(3):243-50. doi: 10.1016/j.ejheart.2006.08.001. Epub 2006 Oct 6.
Other Identifiers
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2012-A01084-39
Identifier Type: OTHER
Identifier Source: secondary_id
1225
Identifier Type: -
Identifier Source: org_study_id
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