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.