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

Overview

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.

Full Title of Study: “Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

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.

Interventions

  • Procedure: Adaptive servo-ventilation post-operative treatment for 6 months

Arms, Groups and Cohorts

  • Experimental: Patients treated by ventilation
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Renaud TAMISIER, MD, PhD, Principal Investigator, University Hospital of Grenoble, France

Citations Reporting on Results

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.

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