Outcome parameters for trials in atrial fibrillation: executive summary

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 VincentGuenter Breithardt

Forskningsoutput: TidskriftsbidragÖversiktsartikelPeer review

Sammanfattning

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.
Originalspråkengelska
Sidor (från-till)2803-2817
TidskriftEuropean Heart Journal
Volym28
Nummer22
DOI
StatusPublished - 2007

Ämnesklassifikation (UKÄ)

  • Kardiologi

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