JACC. Heart failure
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JACC. Heart failure · Oct 2016
Randomized Controlled TrialEfficacy of Sacubitril/Valsartan Relative to a Prior Decompensation: The PARADIGM-HF Trial.
This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. ⋯ Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255).
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JACC. Heart failure · Oct 2016
Patient-Reported Outcomes in Chronic Heart Failure: Applicability for Regulatory Approval.
The study sought to review the characteristics of existing patient-reported outcome (PRO) instruments used with chronic heart failure (HF) patients and evaluate their potential to support an approved U.S. Food and Drug Administration (FDA) product label claim. ⋯ Currently available chronic HF PRO measures do not fulfill all the recommendations provided in the FDA PRO guidance and therefore may not support an FDA-approved product label claim. Future investigations are merited to develop a PRO measure for use in patients with chronic HF in accordance with the FDA guidance.