6/28/23, 10:07 PM EVEREST-Outcomes Pathway Feedback Search Clinical Topics Home Studies EVEREST Outcomes EVEREST Outcomes Disease Heart failure Trial question What is the effect of tolvaptan initiation in patients hospitalized for worsening HF? Study design Multi-center Double blinded RCT Population Characteristics of study participants 26.0% female N = 4133 74.0% male 4133 patients (1058 female, 3075 male) Inclusion criteria: patient hospitalized with HF Key exclusion criteria: cardiac surgery within 60 days of enrollment, cardiac mechanical support, biventricular pacemaker placement within the last 60 days, comorbid conditions with an expected survival < 6 months, acute myocardial infarction at the time of hospitalization, hemodynamically significant uncorrected primary cardiac valvular disease, refractory end- stage HF Interventions N=2072 tolvaptan (30 mg PO once daily for a minimum of 60 days plus standard therapy) N=2061 placebo (matching placebo daily plus standard therapy) Primary outcome All-cause death 26.3 26.3 % 25.9 https://web.pathway.md/studies/recxbJj38p6jG8Zg9 1/2 6/28/23, 10:07 PM EVEREST-Outcomes Pathway 19.7 % 13.2 % 6.6 % No significant difference 0.0 % Tolvaptan Placebo No significant difference in all-cause death (25.9% vs. 26.3%; HR 0.98, 95% CI 0.87 to 1.11) Secondary outcomes No significant difference in cardiovascular death or hospitalization for HF (42% vs. 40.2%; HR 1.04, 95% CI 0.95 to 1.14) No significant difference in cardiovascular death or cardiovascular hospitalization (48.5% vs. 46.4%; HR 1.04, 95% CI 0.95 to 1.14) Safety outcomes No significant difference in major adverse events. Significant differences in thirst (16.0% vs. 2.1%, p < 0.001) and dry mouth (8.4% vs. 2.1%, p < 0.001). Conclusion In patient hospitalized with HF, tolvaptan was not superior to placebo with respect to a all-cause death. Reference Konstam MA, Gheorghiade M, Burnett JC Jr et al. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007 Mar 28;297(12):1319-31. Open reference URL https://web.pathway.md/studies/recxbJj38p6jG8Zg9 2/2