title: Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition.
abstract: 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.
authors.affiliation: 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. f.zannad@chu-nancy.fr
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.forename: Wendy Gattis
authors.initials: WG
authors.lastname: Stough
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.forename: John G F
authors.initials: JG
authors.lastname: Cleland
authors.forename: Kirkwood F
authors.initials: KF
authors.lastname: Adams
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Geller
authors.forename: Christian
authors.initials: C
authors.lastname: Torp-Pedersen
authors.forename: Bridget-Anne
authors.initials: BA
authors.lastname: Kirwan
authors.forename: Ferenc
authors.initials: F
authors.lastname: Follath
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D006333:Heart Failure / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D006801:Humans; D015994:Incidence