An interventional study of Adaptive servo-ventilation post-operative treatment for 6 months in Central Sleep Apneas Syndrome, Heart Failure and Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion, 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 2017-02-02.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
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 :
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 10 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
Adaptive servo-ventilation post-operative treatment for 6 months
Procedure: Adaptive servo-ventilation post-operative treatment for 6 months
Patients not treated during 6 months by an adaptive servo-ventilation
Also known as: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months
Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
Time frame: after 6 months of adaptive servo-ventilation post-operative treatment
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.
Measurement of peripheral arterial tone
Time frame: After 6 months of adaptive servo-sentilation post-operative treatment
Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass 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 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.
Measurement of inflammatory and oxidative serum markers
Time frame: After 6 months of adaptive servo-sentilation post-operative treatment
Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.
By vascular reactivity study of mammary vessels
Time frame: sleep disordered breathing level, 2 months before surgery
Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery.
By immunological and histological analysis of abdominal and epicardiac adipose tissue
Time frame: sleep disordered breathing level, 2 months before surgery
Ran from Jan 2013 to primary completion in May 2015, 28 months.
Of 1,018 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 28 months is close to that.
Counting every sponsor, half of 1,220 studies reached it within 31 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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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