Physicians' Academy for Cardiovascular Education

Towards consensus on appropriate endpoint selection in heart failure clinical trials

News - June 26, 2013

The value of the data obtained in a clinical trial critically depends on endpoint selection in the trial design. Clinical outcomes of interest in heart failure trials range from all-cause or cause-specific mortality and morbidity, to composite endpoints encompassing both mortality and morbidity, to safety and patient-reported outcomes.

Currently, a lack of consensus exists regarding the most appropriate endpoint(s) for clinical importance, sensitivity, reliability and consistency.
As a consequence of greater adoption of evidence-based therapies, event rates decline. Thus, traditional endpoints may no longer be appropriate. Therapeutic goals and underlying event rates differ across the spectrum of patients with acute or chronic heart failure, or heart failure with preserved ejection fraction, thus endpoints need to be tailored to the needs of each population under study.

The Heart Failure Association of the European Society of Cardiology, together with relevant scientific professionals, aimed to develop a consensus framework. The report that summarises the recommendations of this committee for achieving common views on heart failure endpoints in clinical reviews has now been published in the European Journal of Heart Failure [1].

Strengths and weaknesses and controversies or existing consensus about endpoints are discussed. Furthermore, the report identifies areas of uncertainty that require more research.  
The report can serve as a resource for investigators and sponsors who design trials.
 
Source

1. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Zannad F, Alonso Garcia A, Anker SD, et al. Eur J Heart Fail 19 June 2013, 10.1093/eurjhf/hft095