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Abstract
Purpose 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.
Participants 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.
Findings to date 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%).
Future plans 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.
Trial registration number NCT01831128; Pre-results.
- sleep medicine
- cardiology
- heart failure
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Footnotes
J-LP and M-Pd are joint senior authors.
Collaborators The FACE prospective cohort will continue to collect data up to 2 years of follow-up. The findings should allow analysis and generation of clinically relevant data on the use of ASV in a broad range of patients with HF. Access to the FACE study data must be granted by the Steering committee of the study and is therefore not open access. The research team welcomes all potential collaborations with other researchers. For further information, please email the corresponding author at rtamisier@chu-grenoble.fr.
Contributors RT, J-LP, TD, J-MD, SB, FL and M-PD defined the study concept and designed the study. RT, J-LP, TD, J-MD, JAV, AP, FG and M-PD participated to data acquisition. Analysis and interpretation of data were performed by RT, J-LP, TD, J-MD, JAV, SB, AP, FG and M-PD Drafting of the manuscript was done by RT, J-LP, SB and FL. Critical revision of the manuscript for important intellectual content was performed by RT, J-LP, TD, J-MD, JAV, SB, FL, AP, FG and M-PD. Statistical analysis were performed by SB, J-LP and RT. The Study was supervised by RT, J-LP, TD, J-MD, JAV, SB, FL and M-PD.
Funding The FACE study was supported by ResMed.
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.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Ethics approval The study protocol was approved by 'Le Comité consultatif sur le traitement de l’information en matière de recherche en santé' (C.C.T.I.R.S no 09.418) and authorised by the 'Commission Nationale Informatique et Liberté' (C.N.I.L), the French information technology and personal data protection authority.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available. The data are not freely available and access must be granted by the steering committee but we welcome any potential collaboration with other researchers. For further information, please email RT (RTamisier@chu-grenoble.fr).