Trials / Completed
CompletedNCT01900379
PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function
Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Heart Failure
- Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion
- Sleep Apnea, Obstructive
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CPAP 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. |
| OTHER | Sham 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. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2013-07-16
- Last updated
- 2017-02-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01900379. Inclusion in this directory is not an endorsement.