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

Dany Jaffuel, Nicolas Molinari, Philippe Berdague, Atul Pathak, Michel Galinier, Marion Dupuis, Jean-Etienne Ricci, Jean-Pierre Mallet, Arnaud Bourdin, François Roubille, Dany Jaffuel, Nicolas Molinari, Philippe Berdague, Atul Pathak, Michel Galinier, Marion Dupuis, Jean-Etienne Ricci, Jean-Pierre Mallet, Arnaud Bourdin, François Roubille

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.

© 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Study design. AHI, Apnoea–Hypopnoea Index; CHF, chronic heart failure; EQ‐D, EuroQol Group 5‐Dimension Self‐Report Questionnaire; NYHA, New York Heart Association; LVEF, left ventricular ejection fraction; PAP, positive airway pressure.

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