Heart Failure, Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion, Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive sleep apneas syndrome, Continuous positive airway pressure treatment, Heart failure, Coronary reperfusion surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECPAP treatment
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.
OTHERSham CPAP treatment
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.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment | After 3 months of CPAP post-operative treatment | Measurement of the left ventricular ejection fraction by a cardiac ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS. | After 3 months of CPAP post-operative treatment | Measurement of peripheral arterial tone |
| Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG surgery. | 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. | Sleep disordered breathing level, 2 months before surgery | Measuring inflammatory and oxidative adipose markers |
| Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery. | Sleep disordered breathing level, 2 months before surgery | By immunological and histological analysis of abdominal and epicardiac adipose tissue |
| 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. | After 3 months of CPAP post-operative treatment | Measurement of inflammatory and oxidative serum markers |
Countries
France
Outcome results
None listed