Abstract Background EMPEROR-Preserved and EMPEROR-Reduced trials showed the efficacy of empagliflozin (EMP) in reducing cardiovascular death or hospitalization for heart failure (HF), as well as in improving quality of life (QoL), in all 3 types of HF: HF with reduced ejection fraction (HFrEF, LVEF ≤40%), HF with mildly reduced EF (HFmrEF, LVEF = 41-49%), and HF with preserved EF (HFpEF, LVEF ≥50%). Based on these trials, the 2023 updated ESC guidelines recommend EMP treatment for all HF patients. Given the severe impact of HF on QoL, key treatment goals are to improve or maintain QoL, clinical status, and functional capacity. Many HF patients prioritize QoL over longevity, and while treatments like EMP can improve QoL, data on its specific impact in real-world patients with HF is mandatory. Purpose To assess QoL changes and other patient characteristics, over 24 weeks of EMP treatment, in real life, in HF patients from 6 European countries: Bulgaria, Czech Republic, Hungary, Poland, Romania, and Switzerland. Methods Emp-Activity is a multinational, prospective, non-interventional study, which included two cohorts: one cohort receiving EMP as standard therapy of HF, and a second cohort receiving any other HF treatments excluding SGLT2 inhibitors. EMP patients were assessed at baseline and after 24 weeks, while the second cohort only completed baseline. QoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ), with the primary outcome being the change in KCCQ scores from baseline to week 24 for EMP-treated patients. Results This analysis includes 3,309 EMP-treated patients with a mean age of 69.6 ± 10.5 years, 63.1% male, and a mean BMI of 29.7 ± 5.8 kg/m² at baseline. Of these, 1,318 (39.8%) patients were classified as HFrEF, 977 (29.5%) as HFmrEF, and 849 (25.7%) as HFpEF. From baseline to week 24, mean LVEF increased from 42.2 ± 11.1% to 44.4 ± 9.3%, and six-minute walking distance improved from 307.1 ± 130.4 m to 339.0 ± 128.9 m. KCCQ assessment showed an increase in the Overall Summary Score (OSS) from 56.4 ± 22.7 to 72.9 ± 17.8, with 73.0% of EMP patients achieving a clinically meaningful improvement (≥5 points). Stratified by LVEF, OSS increased from 53.9 ± 23.9 to 71.3 ± 18.3 in HFrEF, from 56.6 ± 22.2 to 73.8 ± 16.9 in HFmrEF, and from 60.4 ± 21.1 to 73.8 ± 18.3 in HFpEF. A clinically meaningful improvement was experienced by 74.1% of HFrEF, 75.4% of HFmrEF, and 65.4% of HFpEF patients. Table 1 summarizes patient characteristics and haemodynamic parameters at baseline and week 24. Figure 1 shows detailed KCCQ score changes over 24 weeks. Conclusions Over 24 weeks of EMP treatment, HF patients experienced significant improvements in LVEF, 6-minute walking distance, and KCCQ scores, demonstrating enhanced functional capacity and better QoL. Emp-Activity study provides valuable real-world evidence supporting effectiveness of EMP in achieving key treatment goals.Baseline data Change of KCCQ
Tomaszuk-Kazberuk et al. (Sat,) studied this question.