Document Detail

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.
MedLine Citation:
PMID:  17897925     Owner:  NLM     Status:  MEDLINE    
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.
Paulus Kirchhof; Angelo Auricchio; Jeroen Bax; Harry Crijns; John Camm; Hans-Christoph Diener; Andreas Goette; Gerd Hindricks; Stefan Hohnloser; Lukas Kappenberger; Karl-Heinz Kuck; Gregory Y H Lip; Bertil Olsson; Thomas Meinertz; Silvia Priori; Ursula Ravens; Gerhard Steinbeck; Elisabeth Svernhage; Jan Tijssen; Alphons Vincent; Günter Breithardt
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Publication Detail:
Type:  Consensus Development Conference; Journal Article; Research Support, Non-U.S. Gov't     Date:  2007-09-25
Journal Detail:
Title:  Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology     Volume:  9     ISSN:  1532-2092     ISO Abbreviation:  Europace     Publication Date:  2007 Nov 
Date Detail:
Created Date:  2007-10-18     Completed Date:  2008-03-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883649     Medline TA:  Europace     Country:  England    
Other Details:
Languages:  eng     Pagination:  1006-23     Citation Subset:  IM    
Department of Cardiology and Angiology, University Hospital Münster, Albert-Schweitzer-Strasse 33, D-48149 Münster, Germany.
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MeSH Terms
Atrial Fibrillation / etiology,  physiopathology,  therapy*
Controlled Clinical Trials as Topic / standards*
Disease Progression
Endpoint Determination*
Health Planning Guidelines
Outcome Assessment (Health Care) / standards*
Quality of Life
Treatment Outcome

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