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PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function

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ClinicalTrials.gov Identifier: NCT01741337
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE November 23, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date February 2, 2017
Actual Study Start Date  ICMJE January 29, 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment [ Time Frame: after 6 months of adaptive servo-ventilation post-operative treatment ]
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
  • Assessment of adaptive servo-ventilation effect on the endothelial function, after the surgery in comparison with non treated patient with heart failure and central sleep apneas. [ Time Frame: After 6 months of adaptive servo-sentilation post-operative treatment ]
    Measurement of peripheral arterial tone
  • Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By immunological and histological analysis of mammary vessels
  • Assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity of the abdominal and epicardiac adipose tissue collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    Measuring inflammatory and oxidative adipose markers
  • Assessment of adaptive servo-ventilation effect on 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. [ Time Frame: After 6 months of adaptive servo-sentilation post-operative treatment ]
    Measurement of inflammatory and oxidative serum markers
  • Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By vascular reactivity study of mammary vessels
  • Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By immunological and histological analysis of abdominal and epicardiac adipose tissue
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Assessment of adaptive servo-ventilation effect on the endothelial function, after the surgery in comparison with non treated patient with heart failure and central sleep apneas. [ Time Frame: After 6 months of adaptive servo-sentilation post-operative treatment ]
    Measurement of peripheral arterial tone
  • Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By immunological and histological analysis of mammary vessels
  • Assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity of the abdominal and epicardiac adipose tissue collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    Measuring inflammatory and oxidative adipose markers
  • Assessment of adaptive servo-ventilation effect on 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. [ Time Frame: After 6 months of adaptive servo-sentilation post-operative treatment ]
    Measurement of inflammatory and oxidative serum markers
  • Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By vascular reactivity study of mammary vessels
  • Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By immunological and histological analysis of abdominal and epicardiac adipose tissue
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function
Official Title  ICMJE Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
Brief Summary The aim of this clinical trial is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following coronary artery bypass graft surgery or other coronary reperfusion.
Detailed Description

This clinical trial is a pilot study, on patients with central sleep apneas syndrome and heart failure, undergoing coronary artery bypass graft surgery or other coronary reperfusion, and then randomized for the adaptive servo-ventilation treatment application or not after surgery.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Central Sleep Apneas Syndrome
  • Heart Failure
  • Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
Intervention  ICMJE Procedure: Adaptive servo-ventilation post-operative treatment for 6 months
Other Name: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months
Study Arms  ICMJE
  • Experimental: Patients treated by ventilation
    Adaptive servo-ventilation post-operative treatment for 6 months
    Intervention: Procedure: Adaptive servo-ventilation post-operative treatment for 6 months
  • No Intervention: Patients not treated by ventilation
    Patients not treated during 6 months by an adaptive servo-ventilation
Publications * 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. Epub 2006 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
12
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Coronary artery bypass graft surgery or other coronary reperfusion
  • 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:

  • Aortic or mitral valvular surgery
  • Patient already treated for a central SAS
  • Patient with an obstructive SAS
  • Patient with malignant evolutive pathology
  • Pregnant or lactating women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741337
Other Study ID Numbers  ICMJE 1225
2012-A01084-39 ( Other Identifier: ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Renaud TAMISIER, MD, PhD University Hospital of Grenoble, France
PRS Account University Hospital, Grenoble
Verification Date February 2017

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