TY - JOUR
T1 - Outcome parameters for trials in atrial fibrillation: executive summary
AU - Kirchhof, Paulus
AU - Auricchio, Angelo
AU - Bax, Jeroen
AU - Crijns, Harry
AU - Camm, John
AU - Diener, Hans-Christoph
AU - Goette, Andreas
AU - Hindricks, Gerd
AU - Hohnloser, Stefan
AU - Kappenberger, Lukas
AU - Kuck, Karl-Heinz
AU - Lip, Gregory Y. H.
AU - Olsson, Bertil
AU - Meinertz, Thomas
AU - Priori, Silvia
AU - Ravens, Ursula
AU - Steinbeck, Gerhard
AU - Svernhage, Elisabeth
AU - Tijssen, Jan
AU - Vincent, Alphons
AU - Breithardt, Guenter
PY - 2007
Y1 - 2007
N2 - 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.
AB - 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.
KW - atrial brillation
KW - outcome parameter
KW - randomized trial
KW - therapy
KW - treatment
KW - end-point
KW - quality of life
KW - stroke death
KW - left ventricular function
KW - catheter ablation
KW - antiarrhythmic drugs
KW - cardioversion
KW - rate control
KW - rhythm control
KW - anticoagulation
KW - controlled trial
U2 - 10.1093/eurheartj/ehm358
DO - 10.1093/eurheartj/ehm358
M3 - Review article
SN - 1522-9645
VL - 28
SP - 2803
EP - 2817
JO - European Heart Journal
JF - European Heart Journal
IS - 22
ER -