Key result
Proposed in-hospital worsening heart failure definition captures treatment failure and deterioration to improve trial consistency.
Proposes a novel, standardized definition for in-hospital worsening heart failure to improve clinical trial endpoint consistency and patient management.
May standardize in-hospital worsening HF trial endpoints; leaves open prospective validation before clinical adoption.
Outcome measures used for the clinical evaluation of patients with acute heart failure differ between studies and may neither adequately address the characteristic presenting symptoms and signs nor reflect the pathophysiological processes involved. In-hospital worsening of heart failure (WHF) is associated with poor outcomes and thus a potential endpoint conveying clinically meaningful prognostic information. Current definitions of WHF are based on the combination of worsening symptoms and signs and the intensification of treatment during admission. Definitions vary across studies and do not fully account for baseline therapy or circumstances in which there is failure to respond to treatment. Further, there are limited data to inform healthcare professionals as to which patients are most at risk of developing in-hospital WHF. In this opinion piece, we review the definitions for WHF used in recent and ongoing clinical trials and propose a novel definition, which captures failure to respond to treatment as well as clinical worsening (deterioration of symptoms and signs) of the patient's condition. Such a definition, applied consistently across studies, would help clarify the characteristics of patients likely to develop in-hospital WHF, allow comparative assessments of the effectiveness of interventions, and help guide appropriate patient management in order to improve outcomes.
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Clark et al. (2017) conducted a review in acute heart failure. A novel definition for in-hospital worsening heart failure is proposed to capture both failure to respond to treatment and clinical deterioration, aiming to improve consistency across clinical trials.
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