Treatment patterns of heart failure patients with reduced or mildly reduced ejection fraction on dapagliflozin: baseline data from the 3rd interim analysis of two EVOLUTION-HF DEallEF study cohorts
M Paul, A Guth, S Behrus, R Bosch, W Richter, S H Schirmer, C Zugck, J Langel, J Taggeselle, M Klutmann, W Almohamed, M Knapp, D Weinrich, F Roedicker, B AssmusAbstract
Background/Introduction
Heart failure (HF) remains a major global public health challenge. Guideline-directed medical therapy comprises multiple drug classes and is tailored by ejection fraction (EF) and HF etiology. The sodium–glucose co-transporter 2 inhibitor (SGLT2i) dapagliflozin is approved for HF across the EF spectrum; however, real-world evidence remains limited.
Purpose
EVOLUTION-HF DEallEF (NCT06336330) is designed to complement existing evidence on dapagliflozin use and HF treatment patterns in Germany under the multinational EVOLUTION-HF study umbrella, expanding to include patients across all EF categories.
Methods
EVOLUTION-HF DEallEF is a non-interventional, prospective, longitudinal cohort study planned to enrol 1,000 adult patients with chronic HF in Germany: 400 patients with preserved EF (HFpEF; EF ≥50%), 200 patients with mildly reduced EF (HFmrEF; EF 41–49%), and 400 patients with reduced EF (HFrEF; EF ≤40%). Eligible patients are aged ≥18 years and initiated dapagliflozin for HF per EMA-approved label within 14–90 days before enrolment; prior SGLT2i use and type 1 diabetes are exclusion criteria. Data collected include medical history, clinical symptoms, diagnostic, prior and concomitant medications, health care resource utilization, safety and patient-reported outcomes. All analyses are descriptive. The first patient was enrolled in April 2024; enrolment for HFpEF was completed in July 2025 and for HFmrEF in October 2025. HFrEF enrolment is ongoing. We report baseline treatment patterns for the HFpEF and HFmrEF cohorts.
Results
By the data cut-off (25 November 2025), 597 patients were enrolled: 402 in HFpEF and 195 in HFmrEF cohort. The full analysis set comprised 392 HFpEF and 192 HFmrEF patients who met all eligibility criteria. Selected demographics and baseline HF medication are summarized in the table below. In HFpEF cohort, the median age at baseline was 74 years (59% female patients). The median age in HFmrEF cohort was 70 years (31% female patients). In both cohorts most patients received at least one renin–angiotensin–aldosterone system inhibitor [RAAS blocker: ACEi and/or ARB and/or ARNI; HFpEF: 310 (79%); HFmrEF: 162 (84%)] and betablocker [BB: HFpEF: 276 (70%); HFmrEF 148 (77%)]. Aldosterone antagonists (MRA) were prescribed for one fifth of patients in the HFpEF and one third in the HFmrEF cohort.
Conclusion(s)
EVOLUTION-HF DEallEF delivers contemporary real-world evidence on heart failure treatment patterns in Germany. Nearly all patients received concomitant therapies alongside dapagliflozin. In both cohorts, most patients were treated with a RAAS blocker and BB, consistent with individualized comorbidity profiles.EVOLUTION-HF DEallEF_ESC-HF-2026_table#1For image description, please refer to the figure legend and surrounding text.