EVOLUTION-HF DEallEF: a non-interventional study program of patients with heart failure and initiated on dapagliflozin: results of 1st interim analysis

Abstract Background Heart failure (HF) is one of the leading public health issues worldwide. Current guidelines recommend HF treatment using different drug classes depending on ejection fraction (EF) and underlying cause of HF. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are a drug class with a class IA recommendation in the current ESC-guidelines for HF treatment independent of EF. The SGLT2i dapagliflozin is approved for treatment of HF across the entire spectrum of EF in Germany. However, real-world data are limited. Purpose The aim of EVOLUTION-HF DEallEF is to generate data on real-world dapagliflozin use in HF patients independently of EF in Germany under the multinational umbrella EVOLUTION-HF study protocol. Methods EVOLUTION-HF DEallEF is a non-interventional, prospective, longitudinal cohort study. It is planned to enrol a total of 1000 patients with chronic HF in Germany, including 40% patients with preserved (HFpEF; EF ≥ 50%), 20% with mildly reduced (HFmrEF; EF 41-49%), and 40% with reduced EF (HFrEF; EF ≤ 40%). Patients willing to participate, aged ≥18 years, who started dapagliflozin treatment 14 to 90 days prior to enrolment according to the local product label, are eligible for participation. Among reasons for exclusion is previous SGLT2i treatment (including dapagliflozin). Data on medical history, clinical symptoms, previous and concomitant medication and patient-reported outcomes (PROs) are collected. EVOLUTION-HF DEallEF has included its first patient in 04/2024 and is currently open for enrolment. Interim analyses (IA) were planned at predefined timepoints (after 250, 500 enrolled patients and enrolment completion). The three different EF cohorts (HFpEF, HFmrEF, HFrEF) are analysed separately and as a total population. Only descriptive statistical methods are used. Results This 1st IA (data cutoff: 02/12/2024) included 249 patients in the safety set (all patients received at least one dose of dapagliflozin, one patient refused data usage) and 244 patients who fulfilled all eligibility criteria in the full analysis set (FAS). Patients were enrolled in 31 study sites, mainly in office-based cardiologic practices. In the FAS, distribution of patients to HF cohorts was 51% with HFpEF (n=125), 30% with HFmrEF (n=73), and 19% with HFrEF (n=46). Conclusions Patients’ and disease characteristics observed at the time of the first IA are in range with previously published data indicating that a representative cohort of patients newly treated with dapagliflozin for HF are enrolled in EVOLUTION-HF DEallEF. Dysbalance in expected enrolment proportion per EF cohort is mainly caused by exclusion of patients with SGLT2i-pretreatment. The study aims to provide further insights into real-world dapagliflozin treatment for HF in Germany, focussing on clinical and patients’ perspective.