In PARADIGM‐HF, sacubitril/valsartan demonstrated superiority to enalapril in reducing mortality and morbidity in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Several patient‐centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management. OUTSTEP‐HF has been designed to evaluate the effects of sacubitril/valsartan compared with enalapril on non‐sedentary daytime physical activity in patients with HFrEF.
OUTSTEP‐HF is a randomised, actively controlled, double‐blind, double‐dummy study that plans to enrol 600 ambulatory patients with symptomatic HFrEF in 19 European countries. Patients will be randomised 1:1 to receive sacubitril/valsartan 97/103 mg twice‐daily (bid) or enalapril 10 mg bid. The primary objective of the study was to assess changes from baseline (week 0) to week 12 in exercise capacity measured by 6MWT and in daily non‐sedentary daytime activity Physical activity and objective sleep parameters will be measured by accelerometry using a wrist worn device, worn continuously from screening (Week −2) until the end‐of‐study (Week 12). As a co‐primary outcome, changes from baseline in sub‐maximal exercise capacity will be assessed by the 6‐minute walking test. Patient‐ and physician‐reported questionnaires will be used to assess QoL, changes in signs and symptoms of HF and sleep parameters.
OUTSTEP‐HF will be the largest randomized trial in HF to date to use non‐invasive accelerometry to assess whether treatment with sacubitril/valsartan improves patients’ daily physical activity and exercise capacity compared with enalapril.