Heart FailurePAC-IC-SAOSNCT01900379
PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function
A study testing CPAP treatment in people with Heart Failure and Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion, Sleep Apnea, Obstructive
- What is being tested?
- CPAP treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary Artery Bypass Surgery or other coronary reperfusion
- Heart failure patient: with altered left ventricular ejection fraction by ultrasonography (≤ 50% in 2D) or in 3D
Who cannot join
- Aortic or mitral valvular replacement
- Aortic surgery
- Triple stimulator implanted less than 6 months ago
- Patient already treated for a SAOS syndrome
- Patient with a central sleep apnea syndrome
- Patient with malignant evolutive pathology
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion
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.
Read the 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
- Being tested
- CPAP treatment, Sham CPAP treatment
- Keywords
- Obstructive sleep apneas syndrome, Continuous positive airway pressure treatment, Heart failure, Coronary reperfusion surgery
- Medical subject headings
- Heart Failure, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentProcedure or surgery
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.
Sham CPAP treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OSA/CPAP | Experimental | OSA patients intervention : CPAP treatment Receives: Procedure: CPAP treatment |
| OSA/sham CPAP | Sham comparator | OSA patients intervention : Sham CPAP treatment Receives: Other: Sham CPAP treatment |
| control group | No intervention | Patients without any apnea syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 3 months of CPAP post-operative treatment
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After 3 months of CPAP post-operative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud TAMISIER, MD, PhD, Principal investigator, University Hospital of Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900379
- Sponsor's protocol ID
- 1310
- Other IDs
- 2013-A00543-42
- Acronym
- PAC-IC-SAOS
- Status last verified
- Feb 2017
- First submitted
- 5 Jul 2013
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion
- ClinicalTrials.gov ID
- NCT01900379
- Acronym / sponsor ID
- PAC-IC-SAOS / 1310
- Conditions
- Heart Failure, Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion, Sleep Apnea, Obstructive
- Keywords
- Obstructive sleep apneas syndrome, Continuous positive airway pressure treatment, Heart failure, Coronary reperfusion surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSA/CPAP | Experimental | Procedure: CPAP treatmentOSA patients intervention : CPAP treatment |
| OSA/sham CPAP | Sham comparator | Other: Sham CPAP treatmentOSA patients intervention : Sham CPAP treatment |
| control group | No intervention | –Patients without any apnea syndrome |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary Artery Bypass Surgery or other coronary reperfusion
- Heart failure patient: with altered left ventricular ejection fraction by ultrasonography (≤ 50% in 2D) or in 3D
Key exclusion criteria (7 listed)
- Aortic or mitral valvular replacement
- Aortic surgery
- Triple stimulator implanted less than 6 months ago
- Patient already treated for a SAOS syndrome
- Patient with a central sleep apnea syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP treatmentThis 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. | Procedure or surgery | OSA/CPAP |
| Sham CPAP treatmentThis 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. | Other | OSA/sham CPAP |
Primary outcome
Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment
Time frame: After 3 months of CPAP post-operative treatment
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
6 secondary outcomes
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
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.
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.
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.
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.
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.
Time frame: After 3 months of CPAP post-operative treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud TAMISIER, MD, PhD principal investigator
University Hospital of Grenoble, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP treatment in people with Heart Failure and Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment (time frame: After 3 months of CPAP post-operative treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017; AzTrials last refreshed its copy on 26 Oct 2026.