EMA: Guideline on clinical investigation of medicinal products for the treatment of acute heart failure

The current document is a revised version of this Addendum and the text has been updated in relation to certain factors. In particular, patient characteristics that impact on outcome of AHF trials and their evaluation such as, need for standardisation of time of enrolment in clinical trials, time-points to assess symptoms, use of the composite endpoints, value of invasive haemodynamic measurements and role of natriuretic peptides are addressed.