{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T10:09:32Z","timestamp":1771409372149,"version":"3.50.1"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T00:00:00Z","timestamp":1771372800000},"content-version":"vor","delay-in-days":297,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,4,27]],"date-time":"2025-04-27T00:00:00Z","timestamp":1745712000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"AstraZeneca GmbH"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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 \u226518 years of age, who started dapagliflozin treatment 14\u201390 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 DEallEF has included its first patient in April 2024 and is currently open for enrolment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>EVOLUTION-HF DEallEF will deliver relevant insights into real-world dapagliflozin treatment for HF focusing on clinical and patient perspective in Germany.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ehf2.15312","type":"journal-article","created":{"date-parts":[[2025,4,27]],"date-time":"2025-04-27T23:48:15Z","timestamp":1745797695000},"page":"3145-3151","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["EVOLUTION-HF DEallEF: A Non-Interventional Study of Patients with Heart Failure Initiated On Dapagliflozin: Study Design"],"prefix":"10.1093","volume":"12","author":[{"given":"Matthias","family":"Paul","sequence":"first","affiliation":[{"name":"Academy for Diagnostics and Prevention Muenster , Muenster ,","place":["Germany"]},{"name":"Department of Cardiovascular Medicine, Division Steinfurt, University Hospital Muenster , Muenster ,","place":["Germany"]},{"name":"German Society of Cardiologists in Private Practice (BNK) , Muenchen ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ralph","family":"Bosch","sequence":"additional","affiliation":[{"name":"German Society of Cardiologists in Private Practice (BNK) , Muenchen ,","place":["Germany"]},{"name":"Cardio Centrum Ludwigsburg-Bietigheim (CCLB) , Ludwigsburg ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Behrus","family":"Subin","sequence":"additional","affiliation":[{"name":"German Society of Cardiologists in Private Practice (BNK) , Muenchen ,","place":["Germany"]},{"name":"CardioMed an der Alster Hamburg , Hamburg ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelika","family":"Guth","sequence":"additional","affiliation":[{"name":"German Society of Cardiologists in Private Practice (BNK) , Muenchen ,","place":["Germany"]},{"name":"Promedi Kardiologie , Frankenthal ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marlena","family":"Mueller","sequence":"additional","affiliation":[{"name":"Medical Department, AstraZeneca GmbH , Hamburg ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mareike","family":"Seelinger","sequence":"additional","affiliation":[{"name":"Clinical Operations Department, Alcedis GmbH , Giessen ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Riemann","sequence":"additional","affiliation":[{"name":"Medical Department, AstraZeneca GmbH , Hamburg ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit","family":"Assmus","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology, University of Giessen , Giessen ,","place":["Germany"]},{"name":"Department of Cardiology and DZHK (German Centre for Cardiovascular Research), Partner Site Rhein\/Main, Kerckhoff Heart Center , Bad Nauheim, Hessen ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,4,27]]},"reference":[{"key":"2026021804155316800_ehf215312-bib-0001","doi-asserted-by":"publisher","first-page":"1789","DOI":"10.1016\/S0140-6736(18)32279-7","article-title":"Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990\u20132017: a systematic analysis for the global burden of disease study 2017","volume":"392","author":"GBD 2017 Disease and Injury Incidence and Prevalence Collaborators","year":"2018","journal-title":"Lancet"},{"key":"2026021804155316800_ehf215312-bib-0002","volume-title":"Bundes\u00e4rztekammer (B\u00c4K), Kassen\u00e4rztliche Bundesvereinigung (KBV), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF)"},{"key":"2026021804155316800_ehf215312-bib-0003","volume-title":"H\u00e4ufigste Diagnosen in deutschen Krankenh\u00e4usern nach Fallzahl 2022","author":"Radtke","year":"2024"},{"key":"2026021804155316800_ehf215312-bib-0004","doi-asserted-by":"publisher","first-page":"1150","DOI":"10.1007\/s00392-021-01867-2","article-title":"Timely and individualized heart failure management: need for implementation into the new guidelines","volume":"110","author":"Abdin","year":"2021","journal-title":"Clin Res Cardiol"},{"key":"2026021804155316800_ehf215312-bib-0005","doi-asserted-by":"publisher","first-page":"613","DOI":"10.1002\/ejhf.566","article-title":"European Society of Cardiology Heart Failure Long-Term Registry (ESC-HF-LT): 1-year follow-up outcomes and differences across regions","volume":"18","author":"Crespo-Leiro","year":"2016","journal-title":"Eur J Heart Fail"},{"key":"2026021804155316800_ehf215312-bib-0006","doi-asserted-by":"publisher","first-page":"993","DOI":"10.1056\/NEJMoa1409077","article-title":"Angiotensin\u2013neprilysin inhibition versus enalapril in heart failure","volume":"371","author":"McMurray","year":"2014","journal-title":"N Engl J Med"},{"key":"2026021804155316800_ehf215312-bib-0007","doi-asserted-by":"publisher","first-page":"1995","DOI":"10.1056\/NEJMoa1911303","article-title":"Dapagliflozin in patients with heart failure and reduced ejection fraction","volume":"381","author":"McMurray","year":"2019","journal-title":"N Engl J Med"},{"key":"2026021804155316800_ehf215312-bib-0008","volume-title":"Farxiga highlights of prescribing information","author":"FDA","year":"2014"},{"key":"2026021804155316800_ehf215312-bib-0009","volume-title":"Farxiga NDA approval letter","author":"FDA","year":"2014"},{"key":"2026021804155316800_ehf215312-bib-0010","volume-title":"Forxiga approved in the EU for heart failure","author":"AstraZeneca","year":"2020"},{"key":"2026021804155316800_ehf215312-bib-0011","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1161\/CIRCULATIONAHA.119.044138","article-title":"Effects of dapagliflozin on symptoms, function, and quality of life in patients with heart failure and reduced ejection fraction: results from the DAPA-HF trial","volume":"141","author":"Kosiborod","year":"2020","journal-title":"Circulation"},{"key":"2026021804155316800_ehf215312-bib-0012","doi-asserted-by":"publisher","first-page":"3599","DOI":"10.1093\/eurheartj\/ehab368","article-title":"2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: developed by the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) with the special contribution of the Heart Failure Association (HFA) of the ESC","volume":"42","author":"McDonagh","year":"2021","journal-title":"Eur Heart J"},{"key":"2026021804155316800_ehf215312-bib-0013","doi-asserted-by":"publisher","first-page":"548","DOI":"10.1136\/heartjnl-2022-321702","article-title":"Prevalence, outcomes and costs of a contemporary, multinational population with heart failure","volume":"109","author":"Norhammar","year":"2023","journal-title":"Heart"},{"key":"2026021804155316800_ehf215312-bib-0014","doi-asserted-by":"publisher","first-page":"1089","DOI":"10.1056\/NEJMoa2206286","article-title":"Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction","volume":"387","author":"Solomon","year":"2022","journal-title":"N Engl J Med"},{"key":"2026021804155316800_ehf215312-bib-0015","volume-title":"Forxiga assessment report","author":"EMA","year":"2022"},{"key":"2026021804155316800_ehf215312-bib-0016","volume-title":"Forxiga approved in the EU for the treatment of symptomatic chronic heart failure","author":"AstraZeneca","year":"2023"},{"key":"2026021804155316800_ehf215312-bib-0017","doi-asserted-by":"publisher","first-page":"3627","DOI":"10.1093\/eurheartj\/ehad195","article-title":"2023 focused update of the 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: developed by the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) with the special contribution of the Heart Failure Association (HFA) of the ESC","volume":"44","author":"McDonagh","year":"2023","journal-title":"Eur Heart J"},{"key":"2026021804155316800_ehf215312-bib-0018","volume-title":"Early treatment of heart failure: a non-interventional observational study programme of patients with heart failure and initiated on dapagliflozin (EVOLUTION HF)","author":"Rosano","year":"2023"},{"key":"2026021804155316800_ehf215312-bib-0019","doi-asserted-by":"publisher","first-page":"1245","DOI":"10.1016\/S0735-1097(00)00531-3","article-title":"Development and evaluation of the Kansas City cardiomyopathy questionnaire: a new health status measure for heart failure","volume":"35","author":"Green","year":"2000","journal-title":"J Am Coll Cardiol"},{"key":"2026021804155316800_ehf215312-bib-0020","doi-asserted-by":"publisher","first-page":"1281","DOI":"10.1111\/bcp.14193","article-title":"The medication adherence report scale: a measurement tool for eliciting patients' reports of nonadherence","volume":"86","author":"Chan","year":"2020","journal-title":"Br J Clin Pharmacol"},{"key":"2026021804155316800_ehf215312-bib-0021","doi-asserted-by":"publisher","first-page":"353","DOI":"10.2165\/00019053-199304050-00006","article-title":"The validity and reproducibility of a work productivity and activity impairment instrument","volume":"4","author":"Reilly","year":"1993","journal-title":"Pharmacoeconomics"},{"key":"2026021804155316800_ehf215312-bib-0022","doi-asserted-by":"publisher","first-page":"606","DOI":"10.1046\/j.1525-1497.2001.016009606.x","article-title":"The PHQ-9: validity of a brief depression severity measure","volume":"16","author":"Kroenke","year":"2001","journal-title":"J Gen Intern Med"},{"key":"2026021804155316800_ehf215312-bib-0023","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.jchf.2022.08.009","article-title":"Heart failure drug treatment\u2013inertia, titration, and discontinuation: a multinational observational study (EVOLUTION HF)","volume":"11","author":"Savarese","year":"2023","journal-title":"JACC Heart Fail"},{"key":"2026021804155316800_ehf215312-bib-0024","doi-asserted-by":"publisher","first-page":"353","DOI":"10.2147\/PROM.S156279","article-title":"The importance of patient-reported outcomes in clinical trials and strategies for future optimization","volume":"9","author":"Mercieca-Bebber","year":"2018","journal-title":"Patient Relat Outcome Meas"}],"container-title":["ESC Heart Failure"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/eschf\/article-pdf\/12\/4\/3145\/66954327\/eschf_12_4_3145.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/eschf\/article-pdf\/12\/4\/3145\/66954327\/eschf_12_4_3145.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T09:16:01Z","timestamp":1771406161000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/eschf\/article\/12\/4\/3145\/8488115"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,27]]},"references-count":24,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025,4,27]]},"published-print":{"date-parts":[[2025,8,1]]}},"URL":"https:\/\/doi.org\/10.1002\/ehf2.15312","relation":{},"ISSN":["2055-5822"],"issn-type":[{"value":"2055-5822","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,8]]},"published":{"date-parts":[[2025,4,27]]},"assertion":[{"value":"2024-12-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}