Importance of Clinical Worsening of Heart Failure Treated in the Outpatient Setting: Evidence from the Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial (PARADIGM-HF).

CONCLUSIONS: -Focusing only on HFh underestimates the frequency of worsening and the serious implications of all manifestations of worsening. For clinical trials conducted in an era of heightened efforts to avoid HFh, inclusion of episodes of outpatient treatment intensification (and ED visits) in a composite outcome adds an important number of events and shortens the time taken to accrue a target number of endpoints in an event-driven trial. Clinical Trial Registration Information-www.clinicaltrials.gov. Identifier: NCT01035255.
PMID: 27143684 [PubMed - as supplied by publisher]

Source: Circulation - April 19, 2016 Category: Cardiology Authors: Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ, PARADIGM-HF Investigators and Committees Tags: Circulation Source Type: research