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Outcome parameters for trials in atrial fibrillation: executive summary

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 European Heart Journal 28(22). p.2803-2817
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. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, 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,... (More)
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. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, 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, more detailed outcome parameters are described. 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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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
atrial brillation, outcome parameter, randomized trial, therapy, treatment, end-point, quality of life, stroke death, left ventricular function, catheter ablation, antiarrhythmic drugs, cardioversion, rate control, rhythm control, anticoagulation, controlled trial
in
European Heart Journal
volume
28
issue
22
pages
2803 - 2817
publisher
Oxford University Press
external identifiers
  • wos:000251035500024
  • scopus:36248929793
ISSN
1522-9645
DOI
10.1093/eurheartj/ehm358
language
English
LU publication?
yes
id
72a201ad-6e5b-44d6-92a4-b03cf006b825 (old id 969169)
date added to LUP
2016-04-01 15:51:22
date last changed
2022-03-30 03:24:48
@article{72a201ad-6e5b-44d6-92a4-b03cf006b825,
  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. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, 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, more detailed outcome parameters are described. 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         = {{1522-9645}},
  keywords     = {{atrial brillation; outcome parameter; randomized trial; therapy; treatment; end-point; quality of life; stroke death; left ventricular function; catheter ablation; antiarrhythmic drugs; cardioversion; rate control; rhythm control; anticoagulation; controlled trial}},
  language     = {{eng}},
  number       = {{22}},
  pages        = {{2803--2817}},
  publisher    = {{Oxford University Press}},
  series       = {{European Heart Journal}},
  title        = {{Outcome parameters for trials in atrial fibrillation: executive summary}},
  url          = {{http://dx.doi.org/10.1093/eurheartj/ehm358}},
  doi          = {{10.1093/eurheartj/ehm358}},
  volume       = {{28}},
  year         = {{2007}},
}