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PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure (PROVE-SAS-AHF)

Primary Purpose

Sleep Apnea Syndrome, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
polygraphy and ECG
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Apnea Syndrome focused on measuring Diagnosis, prognostic marker, polygraphy, echocardiography, ECG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hôpital Henri Mondor
  • Chu Pitie Salpetriere
  • Hôpital BICHAT
  • Chu Saint Etienne

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with acute heart failure

Arm Description

polygraphy, echocardiography, ECG during hospitalisation for acute heart failure

Outcomes

Primary Outcome Measures

Persistence of the severity of SAS at the follow visit (AHI> 15).

Secondary Outcome Measures

type of SAS
Echocardiography parameters ECG Holter, biology
Prognostic at 1 year (mortality and rehospitalization for HF)

Full Information

First Posted
November 10, 2014
Last Updated
August 1, 2019
Sponsor
French Cardiology Society
Collaborators
ResMed Foundation, Henri Mondor University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02317848
Brief Title
PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure
Acronym
PROVE-SAS-AHF
Official Title
PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 29, 2019 (Actual)
Study Completion Date
May 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
ResMed Foundation, Henri Mondor University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Heart Failure
Keywords
Diagnosis, prognostic marker, polygraphy, echocardiography, ECG

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with acute heart failure
Arm Type
Other
Arm Description
polygraphy, echocardiography, ECG during hospitalisation for acute heart failure
Intervention Type
Other
Intervention Name(s)
polygraphy and ECG
Intervention Description
polygraphy and ECG during hospitalisation for acute heart failure to see Persistence of the severity of SAS after 2 months
Primary Outcome Measure Information:
Title
Persistence of the severity of SAS at the follow visit (AHI> 15).
Time Frame
2 months after AHF
Secondary Outcome Measure Information:
Title
type of SAS
Time Frame
2 months after AHF
Title
Echocardiography parameters ECG Holter, biology
Time Frame
2 months after AHF
Title
Prognostic at 1 year (mortality and rehospitalization for HF)
Time Frame
2 months after AHF

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Chu Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital BICHAT
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Chu Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42100
Country
France

12. IPD Sharing Statement

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PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure

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