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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00543-42 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA/CPAP | Experimental | OSA patients intervention : CPAP treatment |
|
| OSA/sham CPAP | Sham Comparator | OSA patients intervention : Sham CPAP treatment |
|
| control group | No Intervention | Patients without any apnea syndrome |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP treatment | Procedure | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 3 months of CPAP post-operative treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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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 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Sham CPAP treatment | Other | 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. |
|
Measurement of pulse wave velocity |
| 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 | 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 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 | 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 | After 3 months of CPAP post-operative treatment |
| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |