Treatment of heart failure in clinical practice: non-interventional observational study on patients with heart failure treated with dapagliflozin (evolution-hf italy)

Abstract Background Heart Failure (HF) is a relevant issue for public health issue: it affects more than 64 million people worldwide1, and its burden is anticipated to increase as the population ages. Dapagliflozin is an inhibitor of the sodium–glucose cotransporter–2 (SGLT2i). In the DAPA–HF trial, dapagliflozin reduced the risk of hospitalisation for HF and death in patients with HFrEF (with or without Type 2 Diabetes) compared to placebo2,3,4. Currently, there is a lack of data on characteristics, treatment profiles, and patient reported outcomes (PROs) of patients initiated on dapagliflozin for HFrEF in clinical practice: the EVOLUTION–HF programme is aimed at answering those questions by collecting real–world data in 13 European Countries, including Italy. The primary objective is to characterise patients initiated on dapagliflozin for the treatment of HFrEF and to estimate occurrence of treatment discontinuations. Secondary objectives include an assessment of Health–related Quality of Life (HR–QoL) by means of the Kansas City Cardiomyopathy Questionnaire (KCCQ), patient–reported adherence to prescriptions of pharmacological treatments for HF (Medication Adherence Report Scale – 5 Item), performance on 6–Minutes Walking Test. Methods The study has an observational, longitudinal, descriptive design. To be enrolled, patients must be 18 years old or older and have initiated treatment with dapagliflozin according to the approved HFrEF label. Patients with a diagnosis of Type 1 Diabetes or previously treated with any SGLT2i are excluded from the study. Follow–up lasts one year from start of treatment. Sample size has been estimated in 250 patients, that will be enrolled in 11 centres. Results The study is currently ongoing, and it will generate evidences on the use and tolerability of dapagliflozin, as well as on treatment patterns of other pharmacological therapies for HF and diabetes. Also, the study will generate data from PROs regarding change of KCCQ across time, adherence to HF therapies in clinical practice, and 6–Minutes Walking Tesst. Multivariate analyses will evaluate association between patients’ characteristics and interruption of treatment, adherence and HR–QoL. The interim analysis will be available in the first months of 2023. Conclusions The EVOLUTION–HF Italy study Il programma di studio EVOLUTION–HF supporterà la pratica clinica con dati originali sull‘uso nel mondo reale delle nuove terapie farmacologiche per l‘HFrEF.