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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01084-39 | Other Identifier | ANSM |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated by ventilation | Experimental | Adaptive servo-ventilation post-operative treatment for 6 months |
|
| Patients not treated by ventilation | No Intervention | Patients not treated during 6 months by an adaptive servo-ventilation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive servo-ventilation post-operative treatment for 6 months | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | after 6 months of adaptive servo-ventilation post-operative treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud TAMISIER, MD, PhD | University Hospital of Grenoble, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Grenoble | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17030014 | Result | Vazir A, Hastings PC, Dayer M, McIntyre HF, Henein MY, Poole-Wilson PA, Cowie MR, Morrell MJ, Simonds AK. A high prevalence of sleep disordered breathing in men with mild symptomatic chronic heart failure due to left ventricular systolic dysfunction. Eur J Heart Fail. 2007 Mar;9(3):243-50. doi: 10.1016/j.ejheart.2006.08.001. Epub 2006 Oct 6. |
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By immunological and histological analysis of mammary vessels |
| 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 | 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 | 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 | 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 | sleep disordered breathing level, 2 months before surgery |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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