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

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.

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kardiologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Cardiac and Cardiovascular Systems hsv//eng
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

Auricchio, Angelo (author)
Bax, Jeroen (author)
Crijns, Harry (author)
Camm, John (author)
Diener, Hans-Christoph (author)
Goette, Andreas (author)
Hindricks, Gerd (author)
Hohnloser, Stefan (author)
Kappenberger, Lukas (author)
Kuck, Karl-Heinz (author)
Lip, Gregory Y. H. (author)
Olsson, BertilLund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine(Swepub:lu)kard-bol (author)
Meinertz, Thomas (author)
Priori, Silvia (author)
Ravens, Ursula (author)
Steinbeck, Gerhard (author)
Svernhage, Elisabeth (author)
Tijssen, Jan (author)
Vincent, Alphons (author)
Breithardt, Guenter (author)
KardiologiSektion II (creator_code:org_t)

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cardiac and Card ...

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