Sleep Apnea SyndromePROVE-SAS-AHFNCT02317848
PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure
A study testing polygraphy and ECG in people with Sleep Apnea Syndrome and Heart Failure, run by French Cardiology Society at 4 sites in France.
Trial summary
The prevalence of sleep-disordered breathing is common in patients with stable chronic heart failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS) and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS is associated with higher mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndrome, Heart Failure
- What is being tested?
- polygraphy and ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2014to 29 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Patient.
- Acute heart failure (stage II, III Killip) having clinical conditions of the European Society of Cardiology guidelines 2005 (26: 384-416) regardless of LVEF.
Who cannot join
- Patients who have not given their consent.
- State of cardiogenic shock.
- SAS known and treated.
- Patients who are not affiliated to a French social security.
- Significant myocardial infarction transmural (ST depression) in the last 3 months.
- Important heart surgery in the last 3 months.
- Resynchronization in the last 3 months.
- Any significant changes in drug or therapy.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Henri Mondor
Créteil, 94010
Chu Pitie Salpetriere
Paris, 75013
Hôpital BICHAT
Paris, 75018
Chu Saint Etienne
Saint-Etienne, 42100
About this study
Official title: PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure.
The prevalence of sleep-disordered breathing is common in patients with stable chronic heart failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS) and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS is associated with higher mortality.
CHF is associated with a high rate of re-hospitalization and significant morbidity and mortality and is considered as a major medical and economic problem. To date, few studies have investigated the prevalence, severity, persistence and the role of SAS during cardiac decompensation. For different pathophysiological considerations, it is assumed that SAS is exacerbated during AHF. Therefore SAS is not conventionally screened during this phase. This assumption has been questioned recently by some studies which showed stability of the type of SAS and its severity between the decompensation episode and the stable HF.
Our hypothesis is that SAS during an AHF episode of CHF will remain stable both in terms of severity and type at three months of decompensation. Thus early polygraphy may be reliable for identifying HF patients with SAS.
Read the detailed description
Sleep apnea syndrome (SAS) is common in stable chronic heart failure (CHF) (60-83%) and is divided into two main types: central SAS (CSAS) and obstructive SAS (OSAS). Several studies have shown an association between SAS and HF severity and prognosis (Damy T, et al. European journal of heart failure 2012, 14(9):1009-1019).
Acute heart failure (AHF) is one of the major complications of CHF. It is assumed that during AHF, the severity of apnea syndrome increases due to increased capillary pressure and blood volume, reason why it is common to screen for a SAS after but not during the decompensation phase to avoid its overestimation. Unfortunately, this screening is often performed only in specialized centers and requires another stay in hospital.
The assumption that the severity of SAS increases during AHF has been questioned recently by some studies. These studies suggest that the prevalence of SAS and type are similar in the acute decompensated phase or after stabilization of HF regarding SAS severity and type. Interestingly, in the study conducted at Padeletti, including 10 patients who underwent polysomnography control just before or immediately after discharge from the hospital, all measured parameters remained stable overall. Padeletti M, et al. Sleep medicine 2009, 10(3):353-360).
Khayat et al (Khayat RN, et al. Journal of cardiac failure 2009, 15(9):739-746) demonstrates stability of SAS 6 weeks after an episode of decompensation. In this study 395 patients with AHF were included with a mean LVEF of 33%, 75% (298) had a SAS with 57% as obstructive and 18% as central SAS (ref). 100% of patients diagnosed with an obstructive SAS during the decompensation phase remained with it 6 weeks later. For central SAS and on the 12 patients with two polygraphies, 4 were reported to change type of SAS which become obstructive.
This raises the question of the importance of early diagnosis of SAS during hospitalization for AHF to allow a more rapid care management.
The aim of this multicenter study is to assess the prevalence, persistence of SAS at 3 months following decompensation as well as the prognostic value at 1 year. If SAS is stable between the episode of the AHF and the return to a stable CHF, treatment of SAS may potentially be considered during the admission phase. The benefit of the therapeutic management will of course be validated by a clinical trial.
- Conditions
- Sleep Apnea Syndrome, Heart Failure
- Being tested
- polygraphy and ECG
- Keywords
- Diagnosis, prognostic marker, polygraphy, echocardiography, ECG
- Medical subject headings
- Sleep Apnea Syndromes, Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polygraphy and ECGOther
polygraphy and ECG during hospitalisation for acute heart failure to see Persistence of the severity of SAS after 2 months
| Study group | Role | What they receive |
|---|---|---|
| patients with acute heart failure | Other | polygraphy, echocardiography, ECG during hospitalisation for acute heart failure Receives: Other: polygraphy and ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of the severity of SAS at the follow visit (AHI> 15).
Measured: 2 months after AHF
Secondary outcomes (3)
type of SAS
Measured: 2 months after AHF
Echocardiography parameters ECG Holter, biology
Measured: 2 months after AHF
Prognostic at 1 year (mortality and rehospitalization for HF)
Measured: 2 months after AHF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion29 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed Foundation, Henri Mondor University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317848
- Sponsor's protocol ID
- 2014-01
- Acronym
- PROVE-SAS-AHF
- Status last verified
- Feb 2019
- First submitted
- 10 Nov 2014
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure.
- ClinicalTrials.gov ID
- NCT02317848
- Acronym / sponsor ID
- PROVE-SAS-AHF / 2014-01
- Conditions
- Sleep Apnea Syndrome, Heart Failure
- Keywords
- Diagnosis, prognostic marker, polygraphy, echocardiography, ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- ResMed Foundation, Henri Mondor University Hospital
- Study start
- Dec 2014
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 17 Dec 2014 (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 prevalence of sleep-disordered breathing is common in patients with stable chronic heart failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS) and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS is associated with higher mortality.
CHF is associated with a high rate of re-hospitalization and significant morbidity and mortality and is considered as a major medical and economic problem. To date, few studies have investigated the prevalence, severity, persistence and the role of SAS during cardiac decompensation. For different pathophysiological considerations, it is assumed that SAS is exacerbated during AHF. Therefore SAS is not conventionally screened during this phase. This assumption has been questioned recently by some studies which showed stability of the type of SAS and its severity between the decompensation episode and the stable HF.
Our hypothesis is that SAS during an AHF episode of CHF will remain stable both in terms of severity and type at three months of decompensation. Thus early polygraphy may be reliable for identifying HF patients with SAS.
Detailed description
Sleep apnea syndrome (SAS) is common in stable chronic heart failure (CHF) (60-83%) and is divided into two main types: central SAS (CSAS) and obstructive SAS (OSAS). Several studies have shown an association between SAS and HF severity and prognosis (Damy T, et al. European journal of heart failure 2012, 14(9):1009-1019).
Acute heart failure (AHF) is one of the major complications of CHF. It is assumed that during AHF, the severity of apnea syndrome increases due to increased capillary pressure and blood volume, reason why it is common to screen for a SAS after but not during the decompensation phase to avoid its overestimation. Unfortunately, this screening is often performed only in specialized centers and requires another stay in hospital.
The assumption that the severity of SAS increases during AHF has been questioned recently by some studies. These studies suggest that the prevalence of SAS and type are similar in the acute decompensated phase or after stabilization of HF regarding SAS severity and type. Interestingly, in the study conducted at Padeletti, including 10 patients who underwent polysomnography control just before or immediately after discharge from the hospital, all measured parameters remained stable overall. Padeletti M, et al. Sleep medicine 2009, 10(3):353-360).
Khayat et al (Khayat RN, et al. Journal of cardiac failure 2009, 15(9):739-746) demonstrates stability of SAS 6 weeks after an episode of decompensation. In this study 395 patients with AHF were included with a mean LVEF of 33%, 75% (298) had a SAS with 57% as obstructive and 18% as central SAS (ref). 100% of patients diagnosed with an obstructive SAS during the decompensation phase remained with it 6 weeks later. For central SAS and on the 12 patients with two polygraphies, 4 were reported to change type of SAS which become obstructive.
This raises the question of the importance of early diagnosis of SAS during hospitalization for AHF to allow a more rapid care management.
The aim of this multicenter study is to assess the prevalence, persistence of SAS at 3 months following decompensation as well as the prognostic value at 1 year. If SAS is stable between the episode of the AHF and the return to a stable CHF, treatment of SAS may potentially be considered during the admission phase. The benefit of the therapeutic management will of course be validated by a clinical trial.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute heart failure | Other | Other: polygraphy and ECGpolygraphy, echocardiography, ECG during hospitalisation for acute heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major Patient.
- Acute heart failure (stage II, III Killip) having clinical conditions of the European Society of Cardiology guidelines 2005 (26: 384-416) regardless of LVEF.
Key exclusion criteria (8 listed)
- Patients who have not given their consent.
- State of cardiogenic shock.
- SAS known and treated.
- Patients who are not affiliated to a French social security.
- Significant myocardial infarction transmural (ST depression) in the last 3 months.
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 |
|---|---|---|
| polygraphy and ECGpolygraphy and ECG during hospitalisation for acute heart failure to see Persistence of the severity of SAS after 2 months | Other | patients with acute heart failure |
Primary outcome
Persistence of the severity of SAS at the follow visit (AHI> 15).
Time frame: 2 months after AHF
3 secondary outcomes
type of SAS
Time frame: 2 months after AHF
Echocardiography parameters ECG Holter, biology
Time frame: 2 months after AHF
Prognostic at 1 year (mortality and rehospitalization for HF)
Time frame: 2 months after AHF
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 5 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polygraphy and ECG in people with Sleep Apnea Syndrome and Heart Failure, run by French Cardiology Society at 4 sites 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 8 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Persistence of the severity of SAS at the follow visit (AHI> 15). (time frame: 2 months after AHF). 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 5 Aug 2019.