Owen D Lyons1, John S Floras2, Alexander G Logan2, Robert Beanlands3, Joaquin Durán Cantolla4, Michael Fitzpatrick5, John Fleetham6, R John Kimoff7, Richard S T Leung8, Geraldo Lorenzi Filho9, Pierre Mayer10, Lisa Mielniczuk3, Debra L Morrison11, Clodagh M Ryan2, Frederic Series12, George A Tomlinson2, Anna Woo2, Michael Arzt13, Sairam Parthasarathy14, Stefania Redolfi15, Takatoshi Kasai16, Gianfranco Parati17, Diego H Delgado2, T Douglas Bradley2. 1. Women's College Hospital, Toronto, ON, Canada. 2. University Health Network/Mount Sinai Hospital, Toronto, ON, Canada. 3. University of Ottawa Heart Institute, Ottawa, ON, Canada. 4. Hospital Universitario Txagorritxu, Vitoria, Spain. 5. Queen's University, Kingston, ON, Canada. 6. Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada. 7. McGill University Health Centre, Montreal, QC, Canada. 8. St Michael's Hospital, Toronto, ON, Canada. 9. Instituto do Coração do Hospital das Clínicas da FMUSP, Sao Paulo, Brazil. 10. Hôpital Hôtel-Dieu du CHUM, Université de Montréal, Montreal, QC, Canada. 11. Capital District Health Authority, Halifax, NS, Canada. 12. Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, QC, Canada. 13. Universitätsklinikum Regensburg, Regensburg, Germany. 14. University of Arizona College of Medicine, Tucson, AZ, USA. 15. Groupe Hospitalier Pitie-Salpetriere Charles Fox, Paris, France. 16. Juntendo University Hospital, Tokyo, Japan. 17. Ospedale San Luca, Milan, Italy.
Abstract
INTRODUCTION: Both types of sleep-disordered breathing (SDB), obstructive and central sleep apnoea (OSA and CSA, respectively), are common in patients with heart failure and reduced ejection fraction (HFrEF). In such patients, SDB is associated with increased cardiovascular morbidity and mortality but it remains uncertain whether treating SDB by adaptive servo-ventilation (ASV) in such patients reduces morbidity and mortality. AIM: ADVENT-HF is designed to assess the effects of treating SDB with ASV on morbidity and mortality in patients with HFrEF. METHODS: ADVENT-HF is a multicentre, multinational, randomized, parallel-group, open-label trial with blinded assessment of endpoints of standard medical therapy for HFrEF alone vs. with the addition of ASV in patients with HFrEF and SDB. Patients with a history of HFrEF undergo echocardiography and polysomnography. Those with a left ventricular ejection fraction ≤45% and SDB (apnoea-hypopnoea index ≥15) are eligible. SDB is stratified into OSA with ≥50% of events obstructive or CSA with >50% of events central. Those with OSA must not have excessive daytime sleepiness (Epworth score of ≤10). Patients are then randomized to receive or not receive ASV. The primary outcome is the composite of all-cause mortality, cardiovascular hospital admissions, new-onset atrial fibrillation requiring anti-coagulation but not hospitalization, and delivery of an appropriate discharge from an implantable cardioverter-defibrillator not resulting in hospitalization during a maximum follow-up time of 5 years. CONCLUSION: The ADVENT-HF trial will help to determine whether treating SDB by ASV in patients with HFrEF improves morbidity and mortality.
RCT Entities:
INTRODUCTION: Both types of sleep-disordered breathing (SDB), obstructive and central sleep apnoea (OSA and CSA, respectively), are common in patients with heart failure and reduced ejection fraction (HFrEF). In such patients, SDB is associated with increased cardiovascular morbidity and mortality but it remains uncertain whether treating SDB by adaptive servo-ventilation (ASV) in such patients reduces morbidity and mortality. AIM: ADVENT-HF is designed to assess the effects of treating SDB with ASV on morbidity and mortality in patients with HFrEF. METHODS: ADVENT-HF is a multicentre, multinational, randomized, parallel-group, open-label trial with blinded assessment of endpoints of standard medical therapy for HFrEF alone vs. with the addition of ASV in patients with HFrEF and SDB. Patients with a history of HFrEF undergo echocardiography and polysomnography. Those with a left ventricular ejection fraction ≤45% and SDB (apnoea-hypopnoea index ≥15) are eligible. SDB is stratified into OSA with ≥50% of events obstructive or CSA with >50% of events central. Those with OSA must not have excessive daytime sleepiness (Epworth score of ≤10). Patients are then randomized to receive or not receive ASV. The primary outcome is the composite of all-cause mortality, cardiovascular hospital admissions, new-onset atrial fibrillation requiring anti-coagulation but not hospitalization, and delivery of an appropriate discharge from an implantable cardioverter-defibrillator not resulting in hospitalization during a maximum follow-up time of 5 years. CONCLUSION: The ADVENT-HF trial will help to determine whether treating SDB by ASV in patients with HFrEF improves morbidity and mortality.
Authors: Victoria M Pak; Lisa Strouss; Henry K Yaggi; Nancy S Redeker; Vahid Mohsenin; Barbara Riegel Journal: J Sleep Res Date: 2018-11-13 Impact factor: 3.981
Authors: Elisa Perger; Toru Inami; Owen D Lyons; Hisham Alshaer; Stephanie Smith; John S Floras; Alexander G Logan; Michael Arzt; Joaquin Duran Cantolla; Diego Delgado; Michael Fitzpatrick; John Fleetham; Takatoshi Kasai; R John Kimoff; Richard S T Leung; Geraldo Lorenzi Filho; Pierre Mayer; Lisa Mielniczuk; Debra L Morrison; Gianfranco Parati; Sairam Parthasarathy; Stefania Redolfi; Clodagh M Ryan; Frederic Series; George A Tomlinson; Anna Woo; T Douglas Bradley Journal: J Clin Sleep Med Date: 2017-11-15 Impact factor: 4.062