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Published on: February 26, 2013
Outcome parameters for trials in atrial fibrillation: recommendations from a consensus conference organized by the
Paulus Kirchhof1, Angelo Auricchio, Jeroen Bax
1Department of Cardiology and Angiology, University Hospital Münster, Albert-Schweitzer-Strasse 33, D-48149 Münster, Germany. kirchhp@uni-muenster.de
Insights
Atrial fibrillation (AF) trials need comprehensive outcome assessments. This consensus outlines key parameters across seven domains to better evaluate new AF treatments and reduce patient morbidity and mortality.
Area of Science:
- Cardiology
- Clinical Trials
- Medical Research
Background:
- Atrial fibrillation (AF) is a common arrhythmia with significant morbidity and mortality.
- Current therapies for AF incompletely address its complex consequences like stroke and heart failure.
- New AF treatments are under investigation, necessitating robust evaluation methods.
Framework:
- Expert consensus on required outcome parameters for AF clinical trials.
- Defines seven essential outcome domains: death, stroke, symptoms/quality of life, rhythm, left ventricular function, cost, and emerging parameters.
- Provides detailed outcome parameters within each domain for comprehensive assessment.
Implementation:
- Trials must select a relevant primary outcome.
- Ensures coverage of all major AF-related morbidity and mortality domains.
- Standardizes outcome assessment for improved comparability and interpretation of AF trial results.
Implications:
- Improved evaluation of novel AF therapies.
- Better understanding of AF's impact on patient outcomes.
- Guidance for designing future clinical trials in atrial fibrillation.
- Potential to reduce AF-related burden of disease through optimized treatment strategies.
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. 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.
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