919-19 | Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

Overview

“A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active Controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) versus valsartan on Changes in NT-proBNP and Safety and Tolerability of HFpEF Patients with a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time or Within 30 Days Post-Decompensation (PARAGLIDE-HF)”

Hospitalization for acute decompensated heart failure (ADHF) identifies patients at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel treatment strategies initiated prior to hospital discharge to improve patient outcomes. Patients with ADHF are known to have markedly elevated levels of BNP and NT-proBNP, which are reduced following adequate treatment and normalization of their cardiac decompensation. In a previous study, patients with both a recent hospitalization and elevated NT-ProBNP had a greater risk of cardiovascular death and subsequent heart failure hospitalization. Therefore, it is important to evaluate therapeutic strategies that can lead to superior reductions in NT-proBNP in patients hospitalized due to acute decompensation. Sacubitril/valsartan has been evaluated for safety and efficacy in ambulatory patients with chronic HFpEF. The purpose of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan vs. valsartan on time averaged proportional change in NT-proBNP in patients with HFpEF who have been stabilized during hospitalization for acute decompensated heart failure.