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. 2020 Mar 24;2(2):73–90. doi: 10.36628/ijhf.2020.0002

Table 1. Patient entry criteria used in the PARADIGM-HF study.

Key inclusion criteria Key exclusion criteria
• Age ≥18 years; LVEF ≤40% (later changed to ≤35% • Systolic BP <100 mmHg at screening or <95 mmHg at randomization
• Current symptomatic HF (NYHA class II–IV) • eGFR <30 mL/min/1.73m2 at screening or at randomization or a decrease in eGFR >25% (later amended to 35%) between screening and randomization
• Taking an ACEI or ARB with stable dose of ACEI or ARB and beta blocker for at least 4 weeks • History of angioedema or other unacceptable side effects with ACEIs or ARBs
• BNP ≥150 pg/mL or NT-proBNP ≥600 pg/mL or BNP ≥100 pg/mL or NT-proBNP ≤400 pg/mL for patients hospitalized within the past 12 months

ACEI = angiotensin converting enzyme inhibitor; ARB = angiotensin receptor blocker; BNP = B-type natriuretic peptide; BP = blood pressure; eGFR = estimated glomerular filtration rate; HF = heart failure; LVEF = left ventricular ejection fraction; NT-proBNP = N-terminal pro-B-type natriuretic peptide; NYHA = New York Heart Association; PARADIGM-HF = Prospective Comparison of angiotensin receptor-neprilysin inhibitor (ARNI) with angiotensin converting enzyme inhibitor (ACEI) to Determine Impact on Global Mortality and Morbidity in Heart Failure.