Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

Inclusion criteria

• Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs & Symptoms
• Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
• Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
• Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
• Meeting one of the following criteria:

• Patients on any dose of ACEI or ARB at screening
• ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening.

Exclusion criteria

• History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients.
• Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
• End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
• Serum potassium above 5.4 mmol/L at Randomization.
• Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
• Severe hepatic impairment, biliary cirrhosis and cholestasis