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OUTSTEP‐HF: randomised controlled trial comparing short‐term effects of sacubitril/valsartan versus enalapril on daily physical activity in patients with chronic heart failure with reduced ejection fraction
Author(s) -
Piepoli Massimo F.,
Hussain Rizwan I.,
CominColet Josep,
Dosantos Ramon,
Ferber Philippe,
Jaarsma Tiny,
Edelmann Frank
Publication year - 2021
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.2076
Subject(s) - enalapril , sacubitril , medicine , sacubitril, valsartan , valsartan , heart failure , ejection fraction , cardiology , ambulatory , confidence interval , angiotensin converting enzyme , blood pressure
Aims OUTSTEP‐HF compared the effect of sacubitril/valsartan vs. enalapril on 6‐min walk test (6MWT) distance, non‐sedentary daytime physical activity and heart failure (HF) symptoms in patients with HF with reduced ejection fraction (HFrEF). Methods and results Ambulatory patients ( n = 621) with stable symptomatic HFrEF were randomised 1:1 to sacubitril/valsartan ( n = 310) or enalapril ( n = 311). Changes in physical activity and mean daily non‐sedentary daytime activity from baseline to Week 12 were measured using 6MWT and a wrist‐worn accelerometer device, respectively. After 12 weeks, 6MWT improved by 35.09 m with sacubitril/valsartan [97.5% confidence interval (CI) 27.85, 42.32] and by 26.11 m with enalapril (97.5% CI 18.78, 33.43); however, there was no significant difference between groups [least squares means treatment difference: 8.98 m (97.5% CI −1.31, 19.27); P = 0.0503]. Mean daily non‐sedentary daytime activity decreased by 27 min with sacubitril/valsartan and by 21 min with enalapril [least squares means treatment difference: −6 min (97.5% CI −25.7, 13.4), P = 0.4769] after 12 weeks. 6MWT improved by ≥30 m in 51% of patients in the sacubitril/valsartan group vs. 44% of patients treated with enalapril (odds ratio 1.251, 95% CI 0.895, 1.748). At Week 4, non‐sedentary daytime activity increased by ≥10% in 58% of patients treated with sacubitril/valsartan vs. 64% with enalapril; 58% of patients treated with sacubitril/valsartan reported improved HF symptoms as assessed by patient global assessment vs. 43% with enalapril. However, these differences did not persist at Week 12. Conclusion After 12 weeks of treatment, there was no significant benefit of sacubitril/valsartan on either 6MWT or daytime physical activity measured by actigraphy compared with enalapril.