{"id":"c55ba85a997d","type":"article","url":"https://hartvaat.nl/2025/01/07/euroheart-definities-van-klinische-studie-eindpunten-voor-cvd/","title":"EuroHeart: definities van klinische studie-eindpunten voor CVD","title_en":"Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart).","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehae724","source_url":"https://doi.org/10.1093/eurheartj/ehae724","authors":["Chris Wilkinson","Asad Bhatty","Gorav Batra","Suleman Aktaa","Adam B Smith","Jeremy Dwight","Marcin Ruciński","Sam Chappell","Joakim Alfredsson","David Erlinge","Jorge Ferreira","Ingibjörg J Guðmundsdóttir","Þórdís Jóna Hrafnkelsdóttir","Inga Jóna Ingimarsdóttir","Alar Irs","András Jánosi","Zoltán Járai","Manuel Oliveira-Santos","Bogdan A Popescu","Peter Vasko","Dragos Vinereanu","Jonathan Yap","Raffaele Bugiardini","Edina Cenko","Ramesh Nadarajah","Matthew R Sydes","Stefan James","Aldo P Maggioni","Lars Wallentin","Barbara Casadei","Chris P Gale"],"significance":5,"published":"2025-01-07","source_date":"2025-01-07","image":"","kennis":[],"congress":"","summary_en":"The EuroHeart project standardised definitions for clinical study outcome measures in cardiovascular disease across registries and trials. Uniform endpoint definitions are essential for producing comparable results across European cardiovascular research.","created":"2026-07-03T10:31:25Z","updated":"2026-07-03T13:30:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"EuroHeart-document standaardiseerde de definities van klinische studie-eindpunten voor cardiovasculaire ziekten. Uniforme eindpuntdefinities zijn essentieel voor vergelijkbare resultaten.","abstract_original":"BACKGROUND AND AIMS: Standardized definitions for outcome measures in randomized clinical trials and observational studies are essential for robust and valid evaluation of medical products, interventions, care, and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology aimed to create international data standards for cardiovascular clinical study outcome measures. METHODS: The EuroHeart methods for data standard development were used. From a Global Cardiovascular Outcomes Consortium of 82 experts, five Working Groups were formed to identify and define key outcome measures for: cardiovascular disease (generic outcomes), acute coronary syndrome and percutaneous coronary intervention (ACS/PCI), atrial fibrillation (AF), heart failure (HF) and transcatheter aortic valve implantation (TAVI). A systematic review of the literature informed a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition and categorized the variable as mandatory (Level 1) or optional (Level 2) based on its clinical importance and feasibility. RESULTS: Across the five domains, 24 Level 1 (generic: 5, ACS/PCI: 8, AF: 2; HF: 5, TAVI: 4) and 48 Level 2 (generic: 18, ACS-PCI: 7, AF: 6, HF: 2, TAVI: 15) outcome measures were defined. CONCLUSIONS: Internationally derived and endorsed definitions for outcome measures for a range of common cardiovascular diseases and interventions are presented. These may be used for data alignment to enable high-quality observational and randomized clinical research, audit, and quality improvement for patient benefit."}