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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01741337
First received: November 23, 2012
Last updated: January 16, 2015
Last verified: December 2014
  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 or other coronary reperfusion.


Condition Intervention
Central Sleep Apneas Syndrome
Heart Failure
Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
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 or Other Coronary Reperfusion

Resource links provided by NLM:


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 coronary artery bypass 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: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (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 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.
  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 or other coronary reperfusion
  • heart failure patient: with altered left ventricular ejection fraction by ultrasonography (≤ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: January 16, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
central sleep apneas syndrome
heart failure
all coronary reperfusions
adaptive servo-ventilation treatment

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

ClinicalTrials.gov processed this record on August 03, 2015