. 2019 Jun 19;21(7):932–942. doi: 10.1002/ejhf.1486

Table 2.

Key inclusion and exclusion criteria for the EMPERIAL‐Reduced trial

Key inclusion criteria	Key exclusion criteria
Heart failure diagnosed ≥3 months before screening, and currently in NYHA class II–IV. Reduced ejection fraction, defined as LVEF ≤ 40% (echocardiography) at screening per local reading under stable conditions. 6MWT distance of ≤ 350 m at screening and baseline. Elevated NT‐proBNP (> 450 pg/mL for patients without atrial fibrillation; > 600 pg/mL for patients with atrial fibrillation) at screening. On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥ 4 weeks prior to screening, except for diuretics which must have been stable for ≥ 2 weeks prior to screening. Clinically stable at randomisation with no signs of heart failure decompensation (investigator's judgement).	Myocardial infarction^a, coronary artery bypass graft, or other major cardiovascular surgery, stroke, or transient ischaemic attack within 90 days prior to screening. Acute decompensated heart failure requiring i.v. diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to screening and up to baseline. eGFR (CKD‐EPIcr) < 20 mL/min/1.73 m² or requiring dialysis. Type 1 diabetes. Largest 6MWT distance at baseline < 100 m. Conditions that preclude exercise testing. Atrial fibrillation or atrial flutter with a resting heart rate > 110 b.p.m. documented by echocardiogram at screening

Key inclusion criteria

Key exclusion criteria

Heart failure diagnosed ≥3 months before screening, and currently in NYHA class II–IV.
Reduced ejection fraction, defined as LVEF ≤ 40% (echocardiography) at screening per local reading under stable conditions.
6MWT distance of ≤ 350 m at screening and baseline.
Elevated NT‐proBNP (> 450 pg/mL for patients without atrial fibrillation; > 600 pg/mL for patients with atrial fibrillation) at screening.
On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥ 4 weeks prior to screening, except for diuretics which must have been stable for ≥ 2 weeks prior to screening.
Clinically stable at randomisation with no signs of heart failure decompensation (investigator's judgement).

Myocardial infarction^a, coronary artery bypass graft, or other major cardiovascular surgery, stroke, or transient ischaemic attack within 90 days prior to screening.
Acute decompensated heart failure requiring i.v. diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to screening and up to baseline.
eGFR (CKD‐EPIcr) < 20 mL/min/1.73 m² or requiring dialysis.
Type 1 diabetes.
Largest 6MWT distance at baseline < 100 m.
Conditions that preclude exercise testing.
Atrial fibrillation or atrial flutter with a resting heart rate > 110 b.p.m. documented by echocardiogram at screening

6MWT, 6‐min walk test; CKD‐EPIcr, Chronic Kidney Disease Epidemiology Collaboration creatinine equation; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; NYHA, New York Heart Association.

Increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes.