Key result
Establishing a consensus definition for heart failure in cardiovascular clinical trials is necessary to resolve inconsistencies in determining event incidence and the effects of interventions.
This paper proposes a formal consensus definition for heart failure events in cardiovascular clinical trials to standardize endpoint reporting.
Standardizing HF definitions may enhance trial endpoint consistency; leaves open effects on event rates and intervention assessments.
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.
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Zannad et al. (2008) conducted a review in Heart failure. Establishing a consensus definition for heart failure in cardiovascular clinical trials is necessary to resolve inconsistencies in determining event incidence and the effects of interventions.
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