Outcome parameters for trials in atrial fibrillation: Executive summary - Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork (AFNET) and the European Heart Rhythm Association (EHRA)

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 VincentGünter Breithardt

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)2803-2817
Number of pages15
JournalEuropean Heart Journal
Volume28
Issue number22
DOIs
Publication statusPublished - Nov 2007

Keywords

  • Antiarrhythmic drugs
  • Atrial fibrillation
  • Cardioversion
  • Catheter ablation
  • Controlled trial
  • End-point
  • Left ventricular function
  • Outcome parameter
  • Quality of life
  • Randomized trial
  • Rate control
  • Rhythm control
  • Stroke death
  • Therapy, treatment

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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