Cohort profile: FACE, prospective follow-up of chronic heart failure patients with sleep-disordered breathing indicated for adaptive servo ventilation.

FACE is a prospective cohort study designed to assess the effect of adding adaptive servoventilation (ASV) to standard care on morbidity and mortality in patients with chronic heart failure (HF) with preserved (HFpEF), mid-range (HFmrEF) or reduced ejection fraction (HFrEF) who have sleep-disordered breathing (SDB) with an indication for ASV. We describe the study design, ongoing data collection and baseline participant characteristics. Consecutive patients with HFpEF, HFmrEF or HFrEF plus SDB with central sleep apnoea (CSA) and indication for ASV were enrolled in the study cohort between November 2009 and December 2018; the ASV group includes those treated with ASV and the control group consists of patients who refused ASV or stopped treatment early. Follow-up is based on standard clinical practice, with visits at inclusion, after 3, 12 and 24 months of follow-up. Primary endpoint is the time to first event: all-cause death or unplanned hospitalisation (or unplanned prolongation of a planned hospitalisation) for worsening of HF, cardiovascular death or unplanned hospitalisation for worsening of HF, and all-cause death or all-cause unplanned hospitalisation. 503 patients have been enrolled, mean age of 72 years, 88% male, 31% with HFrEF. HF was commonly of ischaemic origin, and the number of comorbidities was high. SDB was severe (median Apnoea-Hypopnoea Index 42/hour), and CSA was the main indication for ASV (69%). HF was highly symptomatic; most patients were in NYHA class II (38%) or III (29%). Patient follow-up is ongoing. Given the heterogeneous nature of the enrolled population, a decision was made to use latent class analysis to define homogeneous patient subgroups, and then evaluate outcomes by cluster, and in the ASV and control groups (overall and within patient clusters). First analysis will be performed after 3 months, a second analysis at the 2-year follow-up. NCT01831128; Pre-results.

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Competing interests: J-LP, TD, J-MD, RT and M-PD acted as investigators and members of the FACE study steering committee for ResMed. AP and FG acted as investigators of the FACE study for ResMed. RT has received unrestricted research grants from ResMed, Vitalaire, Philips and AGPMC foundation; consultant fees from ResMed, Inspire, Navigant and Jazz Pharmaceuticals; and travel grants from Agiradom. TD reports grant and fees from Pfizer, ResMed, GSG, Alnylam, Akcea, Ionis, Sanofi-Aventis, and Novartis. JAV reports grants and personal fees from ResMed, Bioprojet and Jazz Pharmaceutics; personal fees from Philips, Sanofi, Agfa-Gevaert and Springer; grants from AirLiquide, Westfalen Medical, SomnoMed, Vivisol, Total Care, Medidis, Fisher & Paykel, Wave Medical, OSG, MediqTefa, NightBalance, Heinen & Löwenstein, AstraZeneca, Accuramed, Bekaert Deslee Academy and UCB Pharma. M-PD has received unrestricted research grants from ResMed and Philips; consultant fees from ResMed, Somnomed and Jazz Pharmaceuticals; speaker fees from ResMed, Philips, Lina Nova and Jazz Pharmaceuticals; and travel grants from ISIS medical, Orkyn, SOS Qxygene and Vitalaire. FL is an employee of ResMed.