Baseline characteristics of patients with HFrEF on dapagliflozin: final analysis of baseline data from the EVOLUTION-HF DEallEF study HFrEF cohort

Background Heart failure (HF) is one of the leading public health challenges worldwide. Standard pharmacological HF management combines different drug classes based on the underlying phenotype and left ventricular ejection fraction (LVEF). In HF with reduced LVEF (HFrEF), the guideline-directed therapy should include renin-angiotensin-aldosterone system inhibitor (ARNI/ACEi/ARB), beta-blocker, mineralocorticoid receptor antagonist (MRA), and sodium–glucose cotransporter 2 inhibitor (SGLT2i). Dapagliflozin is a SGLT2i approved for the treatment of HF regardless of EF. Given the limited real-world evidence, the EVOLUTION-HF DEallEF study is currently evaluating patient characteristics, treatment patterns, and the real-world use of dapagliflozin in Germany. Methods EVOLUTION-HF DEallEF is a non-interventional, prospective, longitudinal cohort study planned to enroll 1,000 patients (pts) with chronic HF in Germany: 400 pts with preserved EF (HFpEF; EF ≥50%), 200 pts with mildly reduced EF (HFmrEF; EF >40 to <50%), and 400 pts with reduced EF (HFrEF; EF ≤40%). Eligible participants were adults (≥18 years) who initiated dapagliflozin for HF according to the local product label within 14-90 days before enrollment. Pts with prior SGLT2i therapy or type 1 diabetes were excluded. Collected data encompasses medical history, clinical symptoms, prior and concomitant medications, HF/diabetes treatment patterns, healthcare resource utilization, and patient-reported outcomes. The first patient was enrolled in April 2024. Enrollment for the HFpEF and HFmrEF cohorts was completed in 2025 and for the HFrEF cohort in January 2026. Results After HFpEF/HFmrEF closure, HFrEF recruitment was extended for 3 months. In total, 234 pts were enrolled in the HFrEF cohort and considered for this interim analysis, 228 pts met all eligibility criteria and were included in the full analysis set (data cut-off 02/02/2026). Median age at baseline was 69 years (range 25-94) and 72% of pts were male. Median body mass index was 27.6 kg/m² (range 18.2–54.6) and most pts scored 1-3 on the Clinical Frailty Scale (85.5%). Among other concomitant diseases 68% of pts had arterial hypertension, 16% type 2 diabetes, 16% chronic kidney disease, and 8% suffered from depression. At the start of dapagliflozin treatment, 61% of pts were in NYHA class II, 36% in NYHA class III and 2% in NYHA class IV. Almost all of pts (98%) started dapagliflozin treatment with a daily dose of 10 mg, 2% pts received 5 mg daily. Concomitant HF medications were documented in 96% of pts: 85% received beta-blockers, 79% ARNI/ACEi/ARB, and 59% MRA. Conclusion These EVOLUTION-HF DEallEF data characterize pts with HFrEF in Germany treated with dapagliflozin under routine care conditions. The HFrEF findings reflect the routine practice. Potential gaps between guideline recommendations and real-world medical care may highlight targets for future improvement.