Central Sleep Apneas SyndromeNCT01741337
PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function
A study testing Adaptive servo-ventilation post-operative treatment for 6 months in people with Central Sleep Apneas Syndrome and Heart Failure, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Central Sleep Apneas Syndrome, Heart Failure, Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
- What is being tested?
- Adaptive servo-ventilation post-operative treatment for 6 months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2013to May 2015
- 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 graft surgery or other coronary reperfusion
- heart failure patient: with altered left ventricular ejection fraction by ultrasonography (45%< LVEF ≤ 50% in 2D) or in 3D
- Patient with central sleep apneas syndrome (SAS)
Who cannot join
- Aortic or mitral valvular surgery
- Patient already treated for a central SAS
- Patient with an obstructive SAS
- Patient with malignant evolutive pathology
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
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.
Read the detailed description
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 :
- Assessment of adaptive servo-ventilation effect on the endothelial function, 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.
- Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected only during coronary artery bypass graft 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
- Central Sleep Apneas Syndrome, Heart Failure, Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
- Being tested
- Adaptive servo-ventilation post-operative treatment for 6 months
- Keywords
- central sleep apneas syndrome, heart failure, all coronary reperfusions, adaptive servo-ventilation treatment
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive servo-ventilation post-operative treatment for 6 monthsProcedure or surgery
Also called Adaptive servo-ventilation for sleep-disorderd breathing for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Patients treated by ventilation | Experimental | Adaptive servo-ventilation post-operative treatment for 6 months Receives: Procedure: 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 |
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) improvement conferred by an adaptive servo-ventilation post-operative treatment
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
Measured: after 6 months of adaptive servo-ventilation post-operative treatment
Secondary outcomes (6)
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
Measured: 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
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 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
Measured: 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
Measured: 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
Measured: sleep disordered breathing level, 2 months before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start29 Jan 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Sleep Apneas SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 10 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
- NCT01741337
- Sponsor's protocol ID
- 1225
- Other IDs
- 2012-A01084-39
- Status last verified
- Feb 2017
- First submitted
- 23 Nov 2012
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17030014
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
- ClinicalTrials.gov ID
- NCT01741337
- Acronym / sponsor ID
- 1225
- Conditions
- Central Sleep Apneas Syndrome, Heart Failure, Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
- Keywords
- central sleep apneas syndrome, heart failure, all coronary reperfusions, adaptive servo-ventilation treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 29 Jan 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Dec 2012 (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 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.
Detailed description
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 :
- Assessment of adaptive servo-ventilation effect on the endothelial function, 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.
- Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected only during coronary artery bypass graft 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated by ventilation | Experimental | Procedure: Adaptive servo-ventilation post-operative treatment for 6 monthsAdaptive 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Coronary artery bypass graft surgery or other coronary reperfusion
- heart failure patient: with altered left ventricular ejection fraction by ultrasonography (45%< LVEF ≤ 50% in 2D) or in 3D
- Patient with central sleep apneas syndrome (SAS)
Key exclusion criteria (5 listed)
- Aortic or mitral valvular surgery
- Patient already treated for a central SAS
- Patient with an obstructive SAS
- Patient with malignant evolutive pathology
- Pregnant or lactating women
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 |
|---|---|---|
| Adaptive servo-ventilation post-operative treatment for 6 monthsAlso: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months | Procedure or surgery | Patients treated by ventilation |
Primary outcome
Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment
Time frame: after 6 months of adaptive servo-ventilation post-operative treatment
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
6 secondary outcomes
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.
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.
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 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.
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.
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.
Time frame: sleep disordered breathing level, 2 months before surgery
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 2 Feb 2017.
- Results publication: PubMed 17030014Vazir 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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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 Adaptive servo-ventilation post-operative treatment for 6 months in people with Central Sleep Apneas Syndrome and Heart Failure, 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 3 inclusion and 5 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 2 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. 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) improvement conferred by an adaptive servo-ventilation post-operative treatment (time frame: after 6 months of adaptive servo-ventilation post-operative treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01741337, which also lists 1 linked publication.
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 2 Feb 2017.