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European Heart Journal 2008 29(3):413-421; doi:10.1093/eurheartj/ehm603
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org

Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition

Faiez Zannad1,*, Wendy Gattis Stough2, Bertram Pitt3, John G.F. Cleland4, Kirkwood F. Adams5, Nancy L. Geller6, Christian Torp-Pedersen7, Bridget-Anne Kirwan8 and Ferenc Follath9

1 Hypertension and Preventive Cardiology Division, Department of Cardiovascular Disease, Centre d’Investigations Cliniques INSERM-CHU, INSERM U684, Hôpital Jeanne d’ Arc, 54200 Dommartin-les-Toul, Nancy, France
2 Department of Clinical Research, Campbell University School of Pharmacy, Research Triangle Park, NC, USA
3 University of Michigan, Ann Arbor, MI, USA
4 Department of Cardiology, University of Hull, Kingston-upon-Hull, UK
5 University of North Carolina, Chapel Hill, NC, USA
6 Office of Biostatistics Research, National Heart Lung and Blood Institute, Bethesda, MD, USA
7 University of Copenhagen, Copenhagen, Denmark
8 SOCAR Research, Nyon, Switzerland
9 University Hospital, Zurich, Switzerland

Received 21 May 2007; revised 28 November 2007; accepted 6 December 2007.

*Corresponding author. Tel: +33 383 65 66 25, Fax: +33 383 65 66 19, Email: f.zannad{at}chu-nancy.fr; cic{at}chu-nancy.fr

Specific criteria have been established to define the occurrence of myocardial infarction (MI) and stroke in cardiovascular clinical trials, but there is not a consistent definition for heart failure. Heart failure events appear to occur at a rate that is similar to stroke and MI in trials of hypertension, hyperlipidaemia, diabetes, and coronary heart disease, yet a consistent approach to defining heart failure events has not yet been realized. The wide range of definitions used in clinical trials makes it difficult to interpret new data in the context of existing literature. This inconsistency has led to challenges in determining the incidence of heart failure in cardiovascular studies and the effects of interventions on these endpoints. This paper examines issues related to defining heart failure events in cardiovascular clinical trials and presents a definition to formally address this issue.

Key Words: Cardiovascular disease • Heart failure • Clinical trials • Hypertension • Hypercholesterolaemia


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