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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

Kirchhof, Paulus; Auricchio, Angelo; Bax, Jeroen; Crijns, Harry; Camm, John; Diener, Hans-Christoph; Goette, Andreas; Hindricks, Gerd; Hohnloser, Stefan and Kappenberger, Lukas, et al. (2007) In Europace 9(11). p.1006-1023
Abstract
Atrial fibrillation (AF), the most common atria[ 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... (More)
Atrial fibrillation (AF), the most common atria[ 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. (Less)
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@article{307d1a65-efe0-43d4-96e6-53151b693ebe,
  abstract     = {Atrial fibrillation (AF), the most common atria[ 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.},
  author       = {Kirchhof, Paulus and Auricchio, Angelo and Bax, Jeroen and Crijns, Harry and Camm, John and Diener, Hans-Christoph and Goette, Andreas and Hindricks, Gerd and Hohnloser, Stefan and Kappenberger, Lukas and Kuck, Karl-Heinz and Lip, Gregory Y. H. and Olsson, Bertil and Meinertz, Thomas and Priori, Silvia and Ravens, Ursula and Steinbeck, Gerhard and Svernhage, Elisabeth and Tijssen, Jan and Vincent, Alphons and Breithardt, Guenter},
  issn         = {1532-2092},
  keyword      = {catheter ablation,controlled trial,death,end point,left ventricular function,outcome parameter,quality of life,randomized trial,rate control,stroke,rhythm control,treatment,therapy,cardioversion,atrial fibrillation,antiarrhythmic drugs,anticoagulation},
  language     = {eng},
  number       = {11},
  pages        = {1006--1023},
  publisher    = {Oxford University Press},
  series       = {Europace},
  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},
  url          = {http://dx.doi.org/10.1093/europace/eum191},
  volume       = {9},
  year         = {2007},
}