Purpose of the review: The aim of review is to describe the essential role of study designs beyond RCTs in contemporary contest of HF patients giving perspectives on its evolving. The article concludes with concern about the support of observational studies for future randomized clinical trials.
Recent findings: With the aging population and spectacular advance in cardiovascular therapy, the clinical syndrome comprising heart failure (HF) is increasingly in complexity of heterogeneity. It remains among the most challenging of clinical syndromes with a magnitude of proposed pathophysiological mechanisms involving the heart and the interplay with cardiac and non-cardiac comorbidities. In this epidemiological scenario, randomized clinical trials are suffering from growing failed treatment, so that a deeper understanding of heterogeneity represents a major unmet need. This field also is greatly in a more nuanced comprehension about the applicability in clinical practice of trials' results derived from well-selected HF population. Thus, we need to reflect on trials failures and the translation of previous trials in clinical practice in order to redirect the future trial intervention.
Keywords: Clinical trials; Epidemiology; Heart failure; Registry.