Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition.
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.
Zannad
Faiez
F
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
Stough
Wendy Gattis
WG
Pitt
Bertram
B
Cleland
John G F
JG
Adams
Kirkwood F
KF
Geller
Nancy L
NL
Torp-Pedersen
Christian
C
Kirwan
Bridget-Anne
BA
Follath
Ferenc
F
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