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PAC-IC-SAS Pilot Study

This study is not yet open for participant recruitment.
Verified December 2012 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01741337
First received: November 23, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Central Obstructive Sleep Apneas Syndrome
Heart Failure
Coronary Artery Bypass Graft Surgery
 Procedure: Adaptive servo-ventilation post-operative treatment for 6 months

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]
    Measurement of the left ventricular ejection fraction by a cardiac ultrasonography


Secondary Outcome 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    By immunological and histological analysis of abdominal and epicardiac adipose tissue


Estimated Enrollment: 12
Study Start Date: December 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients treated by ventilation
Adaptive servo-ventilation post-operative treatment for 6 months
 Procedure: Adaptive servo-ventilation post-operative treatment for 6 months
Other Name: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months
No Intervention: Patients not treated by ventilation
Patients not treated during 6 months by an adaptive servo-ventilation

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, 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.

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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery bypass graft surgery
  • heart failure patient: with left ventricular ejection fraction ≤ à 45% by ultrasonography
  • Patient with central sleep apneas syndrome (SAS)

Exclusion Criteria:

  • Aortic or mitral valvular surgery
  • Patient already treated for a central SAS
  • Patient vith an obstructive SAS
  • Patient with malignant evolutive pathology
  • Pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741337

Contacts
Contact: Renaud TAMISIER, MD, PhD 33-476-765-516 RTamisier@chu-grenoble.fr

Locations
France
University Hospital of Grenoble Not yet recruiting
Grenoble, France, 38000
Contact: Renaud TAMISIER, MD, PhD     33-476-765-516     RTamisier@chu-grenoble.fr    
Sub-Investigator: Sandrine LAUNOIS-ROLLINAT, MD, PhD            
Sub-Investigator: Patrick LEVY, MD, PhD            
Sub-Investigator: Jean-Louis PEPIN, MD, PhD            
Sub-Investigator: Vincent BACH, MD            
Sub-Investigator: Olivier CHAVANON, MD, PhD            
Sub-Investigator: Rachid HACINI, MD            
Sub-Investigator: Jean-Philippe BAGUET, MD, PhD            
Sub-Investigator: Gilles BARON-ROCHETTE, MD            
Sub-Investigator: Cécile ROCCA, MD            
Sub-Investigator: Patrice FAURE, MD, PhD            
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Renaud TAMISIER, MD, PhD University Hospital of Grenoble, France
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01741337     History of Changes
Other Study ID Numbers: 1225, 2012-A01084-39
Study First Received: November 23, 2012
Last Updated: December 4, 2012
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
central obstructive sleep apneas syndrome
heart failure
coronary artery bypass graft surgery
adaptive servo-ventilation treatment

Additional relevant MeSH terms:
Apnea
Heart Failure
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013