Design considerations and proposed template for clinical trials in hospitalized patients with decompensated chronic heart failure

It is not possible to develop one design template that will apply to all future trials of heart failure agents. However, it is possible to set a conceptual standard that identifies appropriate eligibility criteria, methodology, and end points. Although there will always be some variation in practice that occurs outside the recommendations made in this article, following the general guidelines described herein when developing clinical trials will aid in the uniformity of clinical research among the heart failure population, and advance the development of new heart failure therapies for this patient population.