Drug development for acute heart failure syndromes: European regulatory view

Abstract

Despite the high prevalence of acute heart failure syndrome (AHFS) associated with its very high rates of morbidity and mortality, little progress has been made in developing new therapies for treatment of this specific clinical condition. Compared with the development of new therapies for other cardiovascular diseases, the lack of progress is striking. Many AHFS trials have displayed negative results and also have raised specific safety concerns in this patient population. To provide regulatory guidance, the European Medicines Agency has recently released Guidance on Clinical Investigations of Medicinal Products for the Treatment of Acute Cardiac Failure (1). To put this guidance into perspective, this chapter discusses issues that are critical for the design of clinical studies in support of regulatory decisions. © 2008 Springer-Verlag London.