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
Open accessAbstract
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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Although cardiac rhythm disorders generally give rise to palpitations, in some subjects arrhythmias including prognostically relevant disorders such as non-sustained ventricular tachycardias and atrial fibrillation may remain completely asymptomatic.
“It is important to underline the fact that, although cardiac rhythm disorders generally give rise to palpitations (or other related symptoms, such as fatigue, dyspnoea, dizziness, syncope, and angina), in some subjects, for reasons not entirely known but probably linked to some clinical characteristics (long-standing arrhythmias with relatively low maximum ventricular rate, male sex, absence of”
From Management of patients with palpitations: a position paper from the European Heart Rhythm Association (2011) · cites this paper as [13]
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Research works printed but not linked: 1
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Cited by
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Self-citationAtrial fibrillation in patients with cryptogenic stroke
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Indications for the use of diagnostic implantable and external ECG loop recorders
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Self-citation
- Authors
- Kirchhof, P., Auricchio, A., Bax, J., Crijns, H., Camm, J., Diener, H.-C., Goette, A., Hindricks, G., Hohnloser, S., Kappenberger, L., Kuck, K.-H., Lip, G. Y. H., Olsson, B., Meinertz, T., Priori, S., Ravens, U., Steinbeck, G., Svernhage, E., Tijssen, J., Vincent, A., & Breithardt, G.
- Affiliations
- University Hospital Münster (DE)
- Istituto Cardiocentro Ticino (CH)
- Maastricht University (NL)
- University of Duisburg-Essen (DE)
- Atrial Fibrillation NETwork (DE)
- Leipzig University (DE)
- Goethe University Frankfurt (DE)
- Birmingham City Hospital (GB)
- Skåne University Hospital (SE)
- Universität Hamburg (DE)
- University of Pavia (IT)
- AstraZeneca (Sweden) (SE)
- Amsterdam UMC Location University of Amsterdam (NL)
- Medtronic (Netherlands) (NL)
- Corresponding author
- Kirchhof, P.
- ORCID
- Venue
- Europace
- Publisher
- Oxford University Press (OUP)
- Published
- 2007-10-03
- Volume
- 9
- Issue
- 11
- Pages
- 1006-1023
- ISSN
- 1099-5129 (ISSN-L)
- 1532-2092
- OpenAlex
- W2004714123
- Cited by
- 293
- References
- 146
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 18 · 2023: 14 · 2022: 14 · 2021: 9 · 2020: 14 · 2019: 12 · 2018: 8 · 2017: 18 · 2016: 15 · 2015: 15 · 2014: 23 · 2013: 26 · 2012: 32
- FWCI
- 10.30
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- EP Europace (publishedVersion)
- PubMed (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- IRIS (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Zenodo (CERN European Organization for Nuclear Research) (other-oa)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Keywords
- atrial fibrillation, primary outcome selection, stroke, mortality, quality of life, clinical symptoms, rhythm control, left ventricular function, cost, antithrombotic therapy, rate control, upstream therapy, consensus recommendations
- MeSH terms
- Atrial Fibrillation, Health Planning Guidelines, Humans, Quality of Life, Treatment Outcome, Outcome Assessment, Health Care, Disease Progression, Controlled Clinical Trials as Topic, Endpoint Determination
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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