Patient Selection and End Point Definitions for Decongestion Studies in Acute Decompensated Heart Failure: Part 1.

Despite recent advances in the treatment of patients with chronic heart failure, acute decompensated heart failure remains associated with significant mortality and morbidity because many novel therapies have failed to demonstrate meaningful benefit. Persistent congestion in the setting of escalating diuretic therapy has been repeatedly shown to be a marker of poor prognosis and is currently being targeted by various emerging device-based therapies. Because these therapies inherently carry procedural risk, patient selection is key in the future trial design. However, it remains unclear which patients are at a higher risk of residual congestion or adverse outcomes despite maximally tolerated decongestive therapy. In the first part of this 2-part review, we aimed to outline patient risk factors and summarize current evidence for early recognition of high-risk profile for residual congestion and adverse outcomes. These factors are classified as relating to the following: (1) previous clinical course, (2) severity of congestion, (3) diuretic response, and (4) degree of renal impairment. We also aimed to provide an overview of key inclusion criteria in recent acute decompensated heart failure trials and investigational device studies and propose potential criteria for selection of high-risk patients in future trials.