Despite the progress made in medical and device-based therapies, prognoses in heart failure (HF) are extremely poor and are worst in patients with acute HF (AHF).1,2 No treatment administered during… Click to show full abstract
Despite the progress made in medical and device-based therapies, prognoses in heart failure (HF) are extremely poor and are worst in patients with acute HF (AHF).1,2 No treatment administered during acute decompensation has been shown to improve outcomes.3 A major limitation in AHF trials has been a lack of short-term outcome endpoints similar to re-infarction in acute coronary syndromes that can represent meaningful endpoints or valid surrogates for long-term post-discharge outcomes, such as mortality and rehospitalization.4,5 Improvement in symptoms, namely dyspnoea, has been used as an endpoint.6–9 However, measurement of dyspnoea relief has poor reproducibility, especially in large multicentre trials, and is influenced by co-morbidities and short-term events, the impacts of which are difficult to quantify.10,11 For these reasons the relation of symptom relief with outcomes is variable and is shown in some studies but not in others.6,9,12–14 In-hospital length of stay (LoS) is clinically meaningful and closely associated with health care expenditure, and has been related to post-discharge outcomes.15–18 However, its large variability across geographical areas makes it less suitable as a parameter in drug assessments in multicentre clinical trials.19 Worsening heart failure (WHF) has emerged as a potential endpoint in clinical trials in patients hospitalized for AHF.20–22 It is defined as a worsening in HF signs and symptoms during an AHF hospitalization that requires the intensification of i.v. therapy and the initiation of inotropic drugs, ultrafiltration or mechanical support.20–22 The persistence of symptoms that caused the hospitalization has been included in the definition of WHF in some
               
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