title: 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.
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.
authors: Department of Cardiology and Angiology, University Hospital Münster, Albert-Schweitzer-Strasse 33, D-48149 Münster, Germany. kirchhp@uni-muenster.de
authors: Paulus
authors: P
authors: Kirchhof
authors: Angelo
authors: A
authors: Auricchio
authors: Jeroen
authors: J
authors: Bax
authors: Harry
authors: H
authors: Crijns
authors: John
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authors: Camm
authors: Hans-Christoph
authors: HC
authors: Diener
authors: Andreas
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authors: Goette
authors: Gerd
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authors: Hindricks
authors: Stefan
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authors: Hohnloser
authors: Lukas
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authors: Kappenberger
authors: Karl-Heinz
authors: KH
authors: Kuck
authors: Gregory Y H
authors: GY
authors: Lip
authors: Bertil
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authors: Olsson
authors: Thomas
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authors: Meinertz
authors: Silvia
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authors: Priori
authors: Ursula
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authors: Ravens
authors: Gerhard
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authors: Steinbeck
authors: Elisabeth
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authors: Svernhage
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authors: Tijssen
authors: Alphons
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authors: Vincent
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authors: Breithardt
mesh_terms: D001281:Atrial Fibrillation / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D018849:Controlled Clinical Trials as Topic / Q000592:standards*; D018450:Disease Progression; D023381:Endpoint Determination; D006287:Health Planning Guidelines; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011788:Quality of Life; D016896:Treatment Outcome