Acute Heart Failure Clinical Trial
Official title:
Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial
This is a prospective multicentre (N=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ED.
Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the
emergency department (ED), with an admission rate higher than 80% and 1-month mortality
around 10%. There is scarce evidence of any clinical added value of a specific treatment to
improve outcomes, and European guidelines for the management of AHF are based on moderate
levels of evidence, due to the lack of randomized controlled trials. Recent reports suggest
that the very early administration of full recommended therapy may decrease mortality.
However, several studies highlighted that elderly patients often received suboptimal
treatment: For example, less than a third of them received nitrates therapy while it is
recommended. Furthermore, a recent preliminary study reported that only 50% of them are
assessed for precipitating factors - although it has been reported that precipitating factors
are independently associated with mortality.
The hypothesis of the Elisabeth Study s is that an early care bundle that comprises early and
comprehensive management of symptoms, along with prompt detection and treatment of
precipitating factors should improve AHF outcome in elderly patients.
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