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Outcome parameters for trials in atrial fibrillation: Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork and the European Heart Rhythm Association

Year: 2007
Type: article
Abstract: Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, 'upstream therapy') only prevent a part of this burden of disease. New treatment modalities are therefore currently under evaluation in clinical trials. Given the multifold clinical consequences of AF, controlled trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these 'requirements' for outcome assessment in AF trials, further outcome parameters are described in each outcome domain. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF-related morbidity and mortality is desirable for any clinical trial in AF.
Source: EP Europace
DOI: 10.1093/europace/eum191
Authors: P. Kirchhof, A. Auricchio, J. Bax, H. Crijns, J. Camm, H.-C. Diener, A. Goette, G. Hindricks, S. Hohnloser, L. Kappenberger, K.-H. Kuck, G. Y.H. Lip, B. Olsson, T. Meinertz, S. Priori, U. Ravens, G. Steinbeck, E. Svernhage, J. Tijssen, A. Vincent, G. Breithardt
Institutions: University Hospital Münster, Atrial Fibrillation NETwork, Istituto Cardiocentro Ticino, Maastricht University, St George's, University of London, British Heart Foundation, University of Duisburg-Essen, Otto-von-Guericke-Universität Magdeburg, Leipzig University, Goethe University Frankfurt, Asklepios Klinik St. Georg, Birmingham City Hospital, Skåne University Hospital, Universität Hamburg, University of Pavia, Technische Universität Dresden, Ludwig-Maximilians-Universität München, AstraZeneca (Sweden), Amsterdam UMC Location University of Amsterdam, Medtronic (Netherlands)
Language: English
Field: Medicine
Open Access status: bronze
OpenAlex ID: W2004714123
FWCI: 9.382
Cites: 151
Cited by: 290
Related to: 10