Table 1.

Key Enrollment Criteria for the PARADIGM‐HF and CHAMP‐HF Studies

Variable	PARADIGM‐HF (N=8442)	CHAMP‐HF (N=5000)
Recruitment time period	2009–2012	2015–2017
Key enrollment criteria
Age, y	≥18	≥18
NYHA class	II–IV	No restriction specified
LVEF, %	≤40a	≤40
Prior HF hospitalization	Yesb	No restriction specified
BNP or NT‐proBNP, pg/mL	BNP ≥150 or NT‐proBNP ≥600b	No restriction specified
eGFR, mL/min per 1.73 m2	≥30	No restriction specified
Systolic BP, mm Hg	≥95	No restriction specified
Potassium, mmol/L	≤5.4	…
Prior medical therapy	ACEI (enalapril, 10 mg/d) or equivalent for 4 wk β Blocker for 4 wk MRA considered	At least 1 oral pharmacotherapy for HF
Run‐in period with active treatment	Yes	Not applicable

ACEI indicates angiotensin‐converting enzyme inhibitor; BNP, B‐type natriuretic peptide; BP, blood pressure; CHAMP‐HF, Change the Management of Patients With Heart Failure; eGFR, estimated glomerular filtration rate; HF, heart failure; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; NYHA, New York Heart Association; PARADIGM‐HF, Prospective Comparison of ARNI [Angiotensin Receptor Neprilysin Inhibitor] With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure.

^aInitially, the required LVEF was ≤40%, but this was changed to ≤35% in a protocol amendment in December 2010.

^bPlasma BNP ≥150 pg/mL (or NT‐proBNP ≥600 pg/mL) at the screening visit or a BNP ≥100 pg/mL (or NT‐proBNP ≥400 pg/mL) with a hospitalization for HF within the past 12 months.