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Funding Information: APM reports personal fees from Novartis during the conduct of the study and personal fees from Bayer, personal fees from AstraZeneca, and personal fees from Fresenius, outside the submitted work. ALC reports personal fees and non‐financial support from Novartis during the conduct of the study. VB declares grants and personal fees from Novartis during the conduct of the study and personal fees from Astra Zeneca and Boehringer Ingelheim‐Lilly Alliance. TD reports grants and personal fees from Pfizer, grants and personal fees from Novartis, grants and personal fees from Bayer, and personal fees from Astra Zeneca, outside the submitted work. JD has nothing to disclose. CF reports personal fees from Novartis during the conduct of the study personal fees from Servier, personal fees and other from AstraZeneca, personal fees and other from Bayer, personal fees and other from Vifor Pharma, personal fees and other from Novartis, and other from Boehringer, outside the submitted work. LHL reports grants and personal fees from Novartis, during the conduct of the study; personal fees from Merck, personal fees from Sanofi, grants and personal fees from Vifor‐Fresenius, grants and personal fees from AstraZeneca, grants and personal fees from Relypsa, personal fees from Bayer, grants from Boston Scientific, personal fees from Pharmacosmos, personal fees from Abbott, grants and personal fees from Mundipharma, personal fees from Medscape, personal fees from Myokardia, and grants and personal fees from Boehringer Ingelheim, outside the submitted work. SK is an employee of GKM (clinical research organization) contracted for data analysis by Novartis and received fees from Novartis during the conduct of the study. PCF and CK are employees of Novartis. RIH was an employee of Novartis when the study was conducted. UZ reports grants and personal fees from Novartis during the conduct of the study and grants and personal fees from Astra Zeneca, personal fees from Boehringer Ingelheim, grants and personal fees from BMS, personal fees from MSD, personal fees from Sanofi, grants and personal fees from Pfizer, personal fees from Trommsdorf, personal fees from Amgen, and grants and personal fees from Bayer, outside the submitted work. Funding Information: This work was supported by Novartis Pharma AG. Publisher Copyright: © 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. Aims: ARIADNE aimed to assess the association between effects of sacubitril/valsartan and no sacubitril/valsartan treatment and clinical characteristics, functional capacity, and clinical outcomes (cause-specific mortality and hospitalizations) in outpatients with heart failure (HF) with reduced ejection fraction (HFrEF). Methods: ARIADNE was a prospective European registry of 9069 patients with HFrEF treated by office-based cardiologists or selected primary care physicians. Of the 8787 eligible for analysis, 4173 patients were on conventional HF treatment (non-S/V group), whereas 4614 patients were either on sacubitril/valsartan treatment at enrolment or started sacubitril/valsartan within 1 month of enrolment (S/V group). We also generated a restricted analysis set (rS/V) including only those 2108 patients who started sacubitril/valsartan treatment within the month prior to or after enrolment. Results: At the baseline, average age of patients enrolled in the study was 68 years, and 23.9% (2099/8787) were female. At the baseline, the proportions of patients with New York Heart Association (NYHA) Class III symptoms were 30.9 (1288/4173), 42.8 (1974/4614), and 48.2% (1015/2108), in non-S/V, S/V, and rS/V groups, respectively. After 12 months of treatment, the proportion of patients with NYHA Class III at baseline who improved to Class II was 32.0% (290/907) in the non-S/V group vs. 46.3% (648/1399) in S/V group and 48.7% (349/717) in rS/V group. The overall mortality rate was 5.0 per 100 patient-years. Rates of HF hospitalizations were high (20.9, 20.3, and 21.2 per 100 patient-years in the non-S/V, S/V, and rS/V groups, respectively). Emergency room visits without hospitalization occurred in 3.9, 3.2, and 3.9% of patients in the non-S/V, S/V, and rS/V groups, respectively. Conclusions: This large HFrEF European registry provides a contemporary outcome profile of outpatients with HFrEF treated with or without sacubitril/valsartan. In a real-world setting, sacubitril/valsartan was associated with an improvement of symptoms in patients with HFrEF compared with the conventional HFrEF treatment. publishersversion published |