Paul Matthias, Bosch Ralph, Subin Behrus, Guth Angelika, Mueller Marlena, Seelinger Mareike, Riemann Stephanie, Assmus Birgit
Academy for Diagnostics and Prevention Muenster, Muenster, Germany.
Department of Cardiovascular Medicine, Division Steinfurt, University Hospital Muenster, Muenster, Germany.
ESC Heart Fail. 2025 Aug;12(4):3145-3151. doi: 10.1002/ehf2.15312. Epub 2025 Apr 27.
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.
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.
EVOLUTION-HF DE will deliver relevant insights into real-world dapagliflozin treatment for HF focusing on clinical and patient perspective in Germany.
心力衰竭（HF）是当今全球主要的公共卫生问题之一。钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）达格列净最近获得了标签扩展。目前在德国，它已被批准用于治疗全射血分数（EF）范围内的HF。然而，真实世界的数据有限。EVOLUTION-HF DE旨在在多国EVOLUTION-HF研究方案的框架下补充德国的现有数据。
EVOLUTION-HF DE（NCT06336330）是一项非干预性、前瞻性、纵向队列研究。计划在德国总共招募1000名（700名可评估）HF患者。计划分配为40%的射血分数保留的患者（HFpEF），20%的射血分数轻度降低的患者（HFmrEF），以及40%的射血分数降低的患者（HFrEF）。年龄≥18岁、根据当地产品标签在入组前14 - 90天开始达格列净治疗的患者有资格参与。排除原因包括既往使用过SGLT2i（包括达格列净）、1型糖尿病以及对达格列净或其辅料过敏。在基线时将回顾性收集达格列净治疗前的病史、HF状况和用药数据。随访数据将涉及临床症状、医疗保健利用情况、HF及合并用药情况以及达格列净的使用情况。这些数据将从患者病历、出院小结和电子病历等真实世界数据源中提取。将前瞻性地每3个月收集一次这些数据，为期12个月。此外，将使用标准化和非标准化问卷收集患者报告的结局（PROs），内容包括健康相关生活质量（HRQoL）、用药依从性、工作效率以及患者的需求、期望和对医疗护理的满意度。主要目标包括患者的人口统计学和临床特征描述以及对达格列净、其他HF药物和降糖药物治疗模式的评估。次要目标是描述HRQoL、用药依从性和工作效率。探索性目标是描述抑郁情况、医疗保健利用情况以及患者的需求、期望和对医疗护理的满意度。EVOLUTION-HF DE于2024年4月纳入了首例患者，目前仍在招募中。
EVOLUTION-HF DE将从临床和患者角度为德国HF的达格列净真实世界治疗提供相关见解。
