Cargando…
Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design
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 i...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5933955/ https://www.ncbi.nlm.nih.gov/pubmed/29469206 http://dx.doi.org/10.1002/ehf2.12270 |
_version_ | 1783320032939343872 |
---|---|
author | Jaffuel, Dany Molinari, Nicolas Berdague, Philippe Pathak, Atul Galinier, Michel Dupuis, Marion Ricci, Jean‐Etienne Mallet, Jean‐Pierre Bourdin, Arnaud Roubille, François |
author_facet | Jaffuel, Dany Molinari, Nicolas Berdague, Philippe Pathak, Atul Galinier, Michel Dupuis, Marion Ricci, Jean‐Etienne Mallet, Jean‐Pierre Bourdin, Arnaud Roubille, François |
author_sort | Jaffuel, Dany |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5933955 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-59339552018-05-10 Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design Jaffuel, Dany Molinari, Nicolas Berdague, Philippe Pathak, Atul Galinier, Michel Dupuis, Marion Ricci, Jean‐Etienne Mallet, Jean‐Pierre Bourdin, Arnaud Roubille, François ESC Heart Fail Study Design 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. John Wiley and Sons Inc. 2018-02-22 /pmc/articles/PMC5933955/ /pubmed/29469206 http://dx.doi.org/10.1002/ehf2.12270 Text en © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Study Design Jaffuel, Dany Molinari, Nicolas Berdague, Philippe Pathak, Atul Galinier, Michel Dupuis, Marion Ricci, Jean‐Etienne Mallet, Jean‐Pierre Bourdin, Arnaud Roubille, François Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design |
title | Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design |
title_full | Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design |
title_fullStr | Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design |
title_full_unstemmed | Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design |
title_short | Impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO‐SAS study design |
title_sort | impact of sacubitril–valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the entresto‐sas study design |
topic | Study Design |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5933955/ https://www.ncbi.nlm.nih.gov/pubmed/29469206 http://dx.doi.org/10.1002/ehf2.12270 |
work_keys_str_mv | AT jaffueldany impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT molinarinicolas impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT berdaguephilippe impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT pathakatul impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT galiniermichel impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT dupuismarion impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT riccijeanetienne impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT malletjeanpierre impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT bourdinarnaud impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign AT roubillefrancois impactofsacubitrilvalsartancombinationinpatientswithchronicheartfailureandsleepapnoeasyndrometheentrestosasstudydesign |