Format

Send to

Choose Destination
ESC Heart Fail. 2018 Jun;5(3):222-230. doi: 10.1002/ehf2.12270. Epub 2018 Feb 22.

Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design.

Author information

1
Department of Pneumology, Arnaud de Villeneuve, Regional University Hospital of Montpellier, 371 Avenue du Doyen Giraud, 34295, Montpellier Cedex 5, France.
2
Department of Medical Information, Montpellier University Hospital, IMAG UMR 5149, Montpellier University, 34090, Montpellier, France.
3
Department of Cardiology, Béziers Hospital, 2 rue Valentin Haûy, BP 740, 34525, Béziers Cedex, France.
4
Department of Cardiovascular Medicine, Hypertension and Heart Failure Unit, Health Innovation Laboratory, Clinique Pasteur, Avenue de Lombez, 31000, Toulouse, France.
5
Department of Cardiology, University Hospital of Rangueil, 1, Avenue Professeur Jean Poulhès, 31095, Toulouse, France.
6
Department of Pneumology, Respiratory Tracts Center, Hôpital Larrey, 24, chemin de Pouvourville, TSA 30030, 31059, Toulouse Cedex 9, France.
7
Department of Cardiology, University Hospital Caremeau, Place du Pr Robert Debré, 30029, Nimes Cedex 9, France.
8
Department of Cardiology, Regional University Hospital of Montpellier, PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR, 9214, Montpellier, France.

Abstract

AIMS:

Sleep-disordered breathing (SDB) is a highly prevalent co-morbidity in patients with chronic heart failure (CHF) and can play a detrimental role in the pathophysiology course of CHF. However, the best way to manage SDB in CHF remains a matter of debate. Sacubitril-valsartan has been included in the 2016 European Society of Cardiology guidelines as an alternative to angiotensin-converting enzyme inhibitors to further reduce the risk of progression of CHF, CHF hospitalization, and death in ambulatory patients. Sacubitril and valsartan are good candidates for correcting SDB of CHF patients because their known mechanisms of action are likely to counteract the pathophysiology of SDB in CHF.

METHODS AND RESULTS:

The ENTRESTO-SAS trial is a 3-month, multicentric, prospective, open-label real-life cohort study. Patients eligible for sacubitril-valsartan treatment (i.e. adults with left ventricular ejection fraction ≤35%, who remain symptomatic despite optimal treatment with an angiotensin-converting enzyme inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist) will be evaluated before and after 3 months of treatment (nocturnal ventilatory polygraphy, echocardiography, laboratory testing, and quality-of-life and SDB questionnaires). The primary outcome is the change in the Apnoea-Hypopnoea Index, before and after 3 months of treatment. One hundred twenty patients are required to detect a significant 20% improvement of the Apnoea-Hypopnoea Index with a power of 90% at an alpha risk of 5%.

CONCLUSIONS:

In the context of the SERVE-HF study, physicians are waiting for new trials and alternative therapies. We sought to assess in the ENTRESTO-SAS trial whether sacubitril-valsartan could improve the outcome of SDB in CHF patients.

KEYWORDS:

Continuous positive airway pressure; Heart failure; Sacubitril-valsartan; Sleep apnoea syndrome; Sleep-disordered breathing

PMID:
29469206
PMCID:
PMC5933955
DOI:
10.1002/ehf2.12270
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for PubMed Central
Loading ...
Support Center