T Douglas Bradley, Alexander G Logan, Geraldo Lorenzi Filho, R John Kimoff, Joaquin Durán Cantolla, Michael Arzt, Stefania Redolfi, Gianfranco Parati, Takatoshi Kasai, Mark E Dunlap, Diego Delgado, Shoichiro Yatsu, Adriana Bertolami, Rodrigo Pedrosa, George Tomlinson, Jose M Marin Trigo, Claudio Tantucci, John S Floras
BACKGROUND: In patients with heart failure and reduced ejection fraction, sleep-disordered breathing, comprising obstructive sleep apnoea (OSA) and central sleep apnoea (CSA), is associated with increased morbidity, mortality, and sleep disruption. We hypothesised that treating sleep-disordered breathing with a peak-flow triggered adaptive servo-ventilation (ASV) device would improve cardiovascular outcomes in patients with heart failure and reduced ejection fraction. METHODS: We conducted a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial of peak-flow triggered ASV in patients aged 18 years or older with heart failure and reduced ejection fraction (left ventricular ejection fraction ≤45%) who were stabilised on optimal medical therapy with co-existing sleep-disordered breathing (apnoea-hypopnoea index [AHI] ≥15 events/h of sleep), with concealed allocation and blinded outcome assessments...
February 2024: Lancet Respiratory Medicine