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PIONEER

Objective

Status Enrolling

Condition Acute Decompensated Heart Failure

Description

Hospitalized subjects

Purpose

Sacubitril and valsartan tablets vs. enalapril on time averaged proportional change in NT-proBNP in patients hospitalized for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%). Hospitalization for acute decompensated heart failure 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. 

Phase IIIb/IV

Key Inclusion Criteria

Currently hospitalized for Acute Decompensated Heart Failure. Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or rales on auscultation or pulmonary congestion on chest x-ray) at time of hospitalization. Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥ 400pg/mL.

Key Exclusion Criteria

Symptomatic hypotension and/or a SBP < 100 mmg Hg, eGFR < 30, requirement of treatment with both ACE inhibitor and ARB, known history of respiratory disorders requiring dilay use if i.v. or oral steroids.

ClinicalTrials.gov Identifier

NCT02254890

Protocol Number

LCZ696BUS01

Principal Investigator(s)
Jason Go, MD

Clinical Trial Categories

  • Cardiology
Sponsor(s)
Novartis
Contact
Dianne Vold, LPN CCRC at 701-780-1559
or dvold@altru.org