NCT02317848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
Last Updated

August 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4.5 years

First QC Date

November 10, 2014

Last Update Submit

August 1, 2019

Conditions

Sleep Apnea SyndromeHeart Failure

Keywords

Diagnosisprognostic markerpolygraphyechocardiographyECG

Outcome Measures

Primary Outcomes (1)

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

    2 months after AHF

Secondary Outcomes (3)

  • type of SAS

    2 months after AHF

  • Echocardiography parameters ECG Holter, biology

    2 months after AHF

  • Prognostic at 1 year (mortality and rehospitalization for HF)

    2 months after AHF

Study Arms (1)

patients with acute heart failure

OTHER

polygraphy, echocardiography, ECG during hospitalisation for acute heart failure

Other: polygraphy and ECG

Interventions

polygraphy and ECGOTHER

polygraphy and ECG during hospitalisation for acute heart failure to see Persistence of the severity of SAS after 2 months

patients with acute heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Henri Mondor

Créteil, 94010, France

Location

Chu Pitie Salpetriere

Paris, 75013, France

Location

Hôpital BICHAT

Paris, 75018, France

Location

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesHeart FailureDisease

Interventions

epicatechin gallate

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

December 17, 2014

Study Start

December 1, 2014

Primary Completion

May 29, 2019

Study Completion

May 29, 2019

Last Updated

August 5, 2019

Record last verified: 2019-02

Locations

FR(4)