USE OF DAPAGLIFLOZIN FOR HEART FAILURE WITH REDUCED EJECTION FRACTION IN ITALIAN CLINICAL PRACTICE (EVOLUTION–HF ITALY): INTERIM ANALYSIS AT 6 MONTHS OF FOLLOW–UP

Abstract Background Dapagliflozin is a sodium–glucose cotransporter–2 inhibitor (SGLT2i) approved for the treatment of Heart Failure (HF); however, real–world data on the use of dapagliflozin in the setting of HF with reduced Ejection Fraction (HFrEF) are scarce. EVOLUTION–HF Italy is part of a wider initiative aimed at filling these gaps with Real–World Evidence studies in 13 European countries. Aims The primary aim of the study is to describe characteristics of patients starting dapagliflozin for HFrEF and treatment patterns including discontinuation of dapagliflozin. Patient Reported Outcomes (PROs) are investigated as secondary aims, including Kansas City Cardiomyopathy Questionnaire (KCCQ), Medication Adherence Report Scale (MARS–5), and 6–Minutes Walking Test (6MWT). This abstract reports interim analysis (IA) results after 6 months of follow–up. Methods EVOLUTION–HF is a descriptive, observational, longitudinal study, which enrolled patients ≥18 years of age initiating dapagliflozin according to the approved HFrEF label; those with previous SGLT2i treatment were excluded. The enrollment window was 14–45 days after dapagliflozin initiation, and follow–up lasts up to 1 year. Results 256 participants (mean age 68.5±11.6 years, 75.8% males) were enrolled in 11 Italian sites between April 2022 and April 2023; baseline clinical characteristics are reported in Figure 1. On average, Left Ventricular Ejection Fraction (LVEF) was 31.9%. Most participants had HF in NYHA class II (69.1%) and with ischaemic aetiology (55.7%); 31.7% were hospitalised for HF in the previous year. Cardiovascular treatments at baseline are detailed in Figure 2: 66.4% of patients were treated according to guideline–directed medical therapy for HFrEF (ARNI or ARB or ACEi + BB + MRA + SGLT2i). Follow–up visits at Month 6 were completed by 99 patients at the time of the IA (Figure 3). At 6 months, when compared with baseline, NTproBNP values lower and clinical status (as assessed by KCCQ score) improved, with patients being highly adherent to HF therapies. Conclusions The interim analysis presented in this abstract indicates signs of clinical improvement 6 months after initiation of dapagliflozin. At study completion (April 2024), EVOLUTION–HF Italy will generate robust evidence on real–world use of dapagliflozin among Italian patients with HFrEF, including relevant information on treatment pattern, clinical parameters, and quality of life.