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Completed

NCT Number: NCT01900379

PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function

The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG) surgery or other coronary reperfusion.

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Key information

Conditions

Heart Failure Apnea Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

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 double-blind, randomized, placebo-controlled study.

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Coronary Artery Bypass Surgery or other coronary reperfusion
  • Heart failure patient: with altered left ventricular ejection fraction by ultrasonography (≤ 50% in 2D) or in 3D

Exclusion criteria

  • Aortic or mitral valvular replacement
  • 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

Treatment and study plan

CPAP treatment

Procedure

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

Other

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.

Primary outcomes

  1. Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment

    Time frame: After 3 months of CPAP post-operative treatment

    Measurement of the left ventricular ejection fraction by a cardiac ultrasonography

Secondary outcomes

  1. Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.

    Time frame: After 3 months of CPAP post-operative treatment

    Measurement of peripheral arterial tone

  2. Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.

    Time frame: After 3 months of CPAP post-operative treatment

    Measurement of pulse wave velocity

  3. Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG surgery.

    Time frame: Sleep disordered breathing level, 2 months before surgery

    By immunological and histological analysis of mammary vessels

  4. 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

  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 immunological and histological analysis of abdominal and epicardiac adipose tissue

  6. Assessment of CPAP effect on the systemic inflammation and oxidative stress, the insulin resistance, after the surgery in comparison with sham CPAP treated patients with heart failure and OSAS.

    Time frame: After 3 months of CPAP post-operative treatment

    Measurement of inflammatory and oxidative serum markers

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion

Acronym: PAC-IC-SAOS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 16, 2013
Registry last updated
Feb 3, 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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