An interventional study of CPAP treatment and Sham CPAP treatment in Heart Failure, Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion and Sleep Apnea, Obstructive, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-02-03.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
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 :
after the coronary reperfusion surgery, in comparison with OSA patients treated with sham CPAP and non apneic control patients, with heart failure.
1,422 studies on the registry are indexed under Apnea; 158 are open to participants now.
This study's enrollment of 17 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University Hospital, Grenoble is the lead sponsor of 816 studies on the registry; 206 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OSA patients intervention : CPAP treatment
Procedure: CPAP treatment
OSA patients intervention : Sham CPAP treatment
Other: Sham CPAP treatment
Patients without any apnea syndrome
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.
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.
Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
Time frame: After 3 months of CPAP post-operative treatment
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
Measurement of peripheral arterial tone
Time frame: After 3 months of CPAP post-operative treatment
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
Measurement of pulse wave velocity
Time frame: After 3 months of CPAP post-operative treatment
Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG surgery.
By immunological and histological analysis of mammary vessels
Time frame: Sleep disordered breathing level, 2 months before surgery
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.
Measuring inflammatory and oxidative adipose markers
Time frame: Sleep disordered breathing level, 2 months before surgery
Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.
By immunological and histological analysis of abdominal and epicardiac adipose tissue
Time frame: Sleep disordered breathing level, 2 months before surgery
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.
Measurement of inflammatory and oxidative serum markers
Time frame: After 3 months of CPAP post-operative treatment
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble