EVOLUTION-HF DEallEF: A non-interventional study of patients with heart failure initiated on dapagliflozin: study design
Abstract
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 DEallEF aims to complement existing data in Germany under the multinational umbrella EVOLUTION-HF study protocol.
Methods: EVOLUTION-HF DEallEF (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…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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