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Completed

NCT Number: NCT01741337

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Grenoble

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptive servo-ventilation post-operative treatment for 6 months

Procedure

Other names: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2012
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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