EVOLUTION-HF DE: A non-interventional study of patients with heart failure initiated on dapagliflozin: study design.

AIMS

Heart failure (HF) is one of today's leading public health issues worldwide. The sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin recently received a label expansion. It is now approved for treatment of HF across the entire spectrum of ejection fraction (EF) in Germany. However, real-world data are limited. EVOLUTION-HF DE aims to complement existing data in Germany under the multinational umbrella EVOLUTION-HF study protocol.

METHODS

EVOLUTION-HF DE (NCT06336330) is a non-interventional, prospective, longitudinal cohort study. It is planned to enrol a total of 1000 (700 evaluable) patients with HF in Germany. Distribution is planned as 40% patients with preserved (HFpEF), 20% with mildly reduced (HFmrEF), and 40% with reduced EF (HFrEF). Patients ≥18 years of age, who started dapagliflozin treatment 14-90 days prior to enrolment according to the local product label, are eligible to participate. Among reasons for exclusion are previous SGLT2i treatment (including dapagliflozin), type 1 diabetes, and hypersensitivity to dapagliflozin or its excipients. Data on medical history, HF status and medication before dapagliflozin treatment will be collected retrospectively at baseline. Follow-up data will concern clinical symptoms, healthcare utilization, HF and concomitant medication, as well as dapagliflozin usage. These data will be extracted from real-world data sources like patient charts, discharge letters, and electronic medical records. They will be collected prospectively every 3 months for up to 12 months. In addition, patient-reported outcomes (PROs) on health-related quality of life (HRQoL), medication adherence, work productivity, and patient's needs, expectations, and satisfaction with medical care will be collected using standardized and unstandardized questionnaires. Primary objectives include demographic and clinical characterization of patients and the assessment of treatment patterns of dapagliflozin, other HF medications, and glucose-lowering medications. Secondary objectives are to describe HRQoL, medication adherence, and work productivity. Exploratory objectives are to describe depression, healthcare utilization, and patient's needs, expectations, and satisfaction with medical care. EVOLUTION-HF DE has included its first patient in April 2024 and is currently open for enrolment.

CONCLUSIONS

EVOLUTION-HF DE will deliver relevant insights into real-world dapagliflozin treatment for HF focusing on clinical and patient perspective in Germany.