End points in heart failure-are we doing it right?

PURPOSE: Heart Failure (HF) continues to be associated with high mortality and morbidity. We attempted to identify the most common end points used in phase 3 clinical trials of heart failure and discuss their merits and demerits.

METHODS: Literature evaluation was done using the databases PubMed and Clinicaltrials.gov from January 2010 to December 2016 to identify randomised clinical trials (RCTs) evaluating the effect of therapeutic drugs on heart failure. Following the literature search, the data on the primary end points were extracted from each of the selected trials. The most recurrent and important end points of Phase III clinical trials for HF over the last six years were identified for further discussion.

RESULTS: From our search, it was observed that the most common end points used in trials with acute heart failure (AHF) were composite end point, dyspnea, CV death and most common end points used in trials with chronic heart failure (CHF) were composite end point, 6 minute walk test (6MWT), CV death or HFH, Vo2 max, all cause mortality, left ventricular ejection fraction (LVEF), and dyspnea.

CONCLUSION: Choosing the appropriate end points is a critical step in the study design that could turn the tide in the beleaguered drug development pipeline of HF, resulting in the right molecule reaching the HF community.