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Rationale and design of the ESC Heart Failure III Registry - Implementation and discovery

Lars H Lund et al. Eur J Heart Fail. 2023 Dec.
Free article

Abstract

Aims: Heart failure outcomes remain poor despite advances in therapy. The European Society of Cardiology Heart Failure III Registry (ESC HF III Registry) aims to characterize HF clinical features and outcomes and to assess implementation of guideline-recommended therapy in Europe and other ESC affiliated countries.

Methods: Between 1 November 2018 and 31 December 2020, 10 162 patients with chronic or acute/worsening HF with reduced, mildly reduced, or preserved ejection fraction were enrolled from 220 centres in 41 European or ESC affiliated countries. The ESC HF III Registry collected data on baseline characteristics (hospital or clinic presentation), hospital course, diagnostic and therapeutic decisions in hospital and at the clinic visit; and on outcomes at 12-month follow-up. These data include demographics, medical history, physical examination, biomarkers and imaging, quality of life, treatments, and interventions - including drug doses and reasons for non-use, and cause-specific outcomes.

Conclusion: The ESC HF III Registry will provide comprehensive and unique insight into contemporary HF characteristics, treatment implementation, and outcomes, and may impact implementation strategies, clinical discovery, trial design, and public policy.

Keywords: Heart failure; Implementation; Phenotyping; Quality of care; Registry.

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Conflict of interest statement

Conflict of interest: There are no conflicts of interest related to the ESC HF III Registry or to this manuscript. Outside of the submitted work, there are the following disclosures: L.H.L. declares grants or contracts from AstraZeneca, Vifor Pharma, Novartis, Boston Scientific, and Boehringer Ingelheim; consulting fees for trial design and/or development/implementation strategy from Merck, Vifor Pharma, AstraZeneca, Bayer, Pharmacosmos, MedScape, Sanofi, Lexicon, Myokardia, Boehringer Ingelheim, and Servier; payment or honoraria for lectures from Abbott, MedScape, Radcliffe, AstraZeneca, and Novartis. He also serves on the Board of the Heart Failure Association of the ESC, the Board of the Swedish Society of Cardiology, HF Working Group and is as a Fellow of the ESC. He reports holding stock in AnaCardio. M.G.C.L. declares grants or contracts from AstraZeneca and Vifor Pharma; consulting fees from Medtronic and Takeda; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Boehringer Ingelheim, Novartis, AstraZeneca, Vifor Pharma, CareDx, Astellas, Abbott, Medtronic, and Bayer; and support for attending meetings and/or travel from Novartis and Abbott. E.B.V. declares payments made to her for honoraria for lectures and/or educational materials/events from Berlin Chemie AG, and Johnson & Johnson; consulting fees for Egis Pharma. A.K.C. declares payments made to her for honoraria for lectures and/or educational materials/events from Angelini Pharma, AstraZeneca, Bayer, Bausch Health, Boehringer Ingelheim, KRKA, Pfizer, Polpharma, and Servier. S.D.A. declares grants for IITs from Vifor Int and Abbott; consulting fees for serving on Ad-hoc advisory board from Novartis, for ad-hoc consultancy from Cordio, Cytokinetics, Faraday Pharmaceuticals, GSK, Sensible Medical, Amgen, Bioventrix, CVRx, Sanofi, and Vectorious, for ad-hoc consultancy/ad-hoc advisory board from Astra Zeneca, Repairon, Novo Nordisk, and Brahms, and for serving on the advisory board from Actimed Therapeutics and HeartKinetics; he reports being named co-inventor of two patent applications on MR-proANP (DE 102007010834 & DE 102007022367) while not benefitting personally from the related issued patents; fees for Covid19 advisory board work from Abbott; serving on the Registry Steering Committee for Servier; doing trial committee work & consultancy for Cardior, trial steering committee work for Impulse Dynamics and Pfizer; trial steering committee work & consultancy for Bayer AG, Boehringer Ingelheim, V-Wave, Cardiac Dimensions, and Occlutech; and trial/registry steering committee work & consultancy for Vifor Int. O.C. reports support for attending ESC Congress from Servier. A.J.S.C.s declares having received honoraria and/or lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Edwards, Eli Lilly, Menarini, Novartis, Servier, Vifor, Abbott, Actimed, Cardiac Dimensions, Corvia, CVRx, Enopace, ESN Cleer, Faraday, Impulse Dynamics, Respicardia, and Viatris. G.F. declares support for the present manuscript (e.g. funding, provision of study materials, medical writing, article processing charges, etc.) and grants or contracts from the European Commission; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, Boehringer Ingelheim; participation in a Data Safety Monitoring Board or Advisory Board from Bayer; and leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid with the Heart Failure Association of the ESC and JACC Heart Failure. T.M. declares payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbott, Edwards, Boehringer and Ingelheim. M.M. reports personal fees of minimal amounts in the last 3 years for consulting from Actelion, Amgen, Livanova and Vifor pharma as member of Executive or Data Monitoring Committees of sponsored clinical trials; from AstraZeneca, Abbott Vascular, Bayer, Boehringer Ingelheim and Edwards Therapeutics for participation in advisory boards and/or speeches at sponsored meetings; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for one sponsored meeting supported by Abbott Vascular. M.P. declares speaker's fees from AstraZeneca, Boehringer Ingelheim and Novo Nordisk; payment for writing or reviewing the manuscript: Menarini, Servier; he serves on the ESC board. G.M.C.R. declares grants or contracts from Ricerca Corrente Ministero della Salute, Italy; and support for attending meetings and/or travel from Menarini, Vifor, AstraZeneca, Boehringer, Bayer, and Servier. F.R. declares not having received personal payments by pharmaceutical companies or device manufacturers in the last 3 years; the Department of Cardiology (University Hospital of Zurich/University of Zurich) reports research, educational and/or travel grants from Abbott, Amgen, AstraZeneca, Bayer, Berlin Heart, B. Braun, Biosense Webster, Biosensors Europe AG, Biotronik, BMS, Boehringer Ingelheim, Boston Scientific, Bracco, Cardinal Health Switzerland, Corteria, Daiichi, Diatools AG, Edwards Lifesciences, Fresenius, Guidant Europe NV (BS), Hamilton Health Sciences, Kaneka Corporation, Kantar, Labormedizinisches Zentrum, Medtronic, MSD, Mundipharma Medical Company, Novartis, Novo Nordisk, Orion, Pfizer, Quintiles Switzerland Sarl, Sahajanand IN, Sanofi, Sarstedt AG, Servier, SIS Medical, SSS International Clinical Research, Terumo Deutschland, Swiss National Foundation, Trama Solutions, V-Wave, Vascular Medical, Vifor, Wissens Plus, ZOLL. The research and educational grants do not impact on Prof. Ruschitzka's personal remuneration; remuneration for the time spent in the following consulting activities were made directly to the University of Zurich, and do not impact on Prof. Ruschitzka's personal remuneration, from AstraZeneca (IMC), Bayer, Boehringer Ingelheim, Citi Research, Klub Class, Novo Nordisk, Radcliffe Group, Stiftung Pfizer Forschungspreis, and Vifor; remuneration for following lectures were made directly to the University of Zurich, and do not impact on Prof. Ruschitzka's personal remuneration, from Abbott, Amgen, AstraZeneca (A+ Science AB), Bayer (At the Limits), Boehringer Ingelheim, Boston Scientific (CCE Services), Brigham and Women's Hospital Boston, C.T.I GmbH, Hôpitaux Universitaires des Genève (GECORE), Luzerner Kantonsspital, Sanofi-Aventis, Servier, Medscape (WebMD), Medtronic, Medworld, Novartis, Roche, Ruwag, Swiss Heart Failure Academy, The Hong Kong Heart Failure Society, Trama Solutions SL, Inselspital Bern, Charité–Universitätsmedizin Berlin (Medical Education Global Solutions), Romanian Society of Cardiology, ÖKG Österreichische Gesellschaft für Kardiologie; Support for attending meetings and/or travel from AstraZeneca (IMC/A+ Science AB), Boehringer Ingelheim, Centro Hospitaler de Vila Nova de Gaia, C.T.I. GmbH (Universitätsklinikum Düsseldorf), European Society of Cardiology, Novartis, Spektar Putovanja, Austrian Heart Failure Association, Heart Failure Association of the ESC; remuneration for following Advisory Boards were made directly to the University of Zurich and do not impact on Prof. Ruschitzka's personal remuneration, from Bayer: HF Expert Summit, Advisory Board Meeting; Roche: Advisory Board Meeting; IMC/AstraZeneca: Advisory Board Meeting; Amgen: Advisory Board Meeting; secretarial and administrative support of the HFA President/Past-President 2018–2020 of the ESC. G.S. reports grants or contracts from Vifor Pharma, Novartis, Boehringer Ingelheim, Boston Scientific, AstraZeneca, Pharmacosmos, Merck, Bayer, Cytokinetics, Horizon 2022 funding; consulting fees from TEVA, MIUR (Ministero dell'Istruzione, Università e Ricerca), Medical Education Global Solutions, Atheneum, Genesis, Vifor Pharma, and Agence Recherche (ANR); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Servier, Cytokinetics, Medtronic, Dynamicom Education, Vifor Pharma, Roche, Translational Medicine Academy Foundation (TMA), Medical Education Global Solutions, AstraZeneca, and Novartis; support for attending meetings and/or travel from Boehringer Ingelheim; participation in a Data Safety Monitoring Board or Advisory Board for AstraZeneca, Uppsala Clinical Research Center (UCR), Servier, Edwards, and Vifor. A.P.M. received grants or contracts for participating in study committees from Novartis, and AstraZeneca. All other authors have nothing to disclose.

References

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