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

Table 1.

Key inclusion and exclusion criteria for the EMPERIAL‐Preserved trial

Key inclusion criteria	Key exclusion criteria
• Heart failure diagnosed ≥ 3 months before screening, and currently in NYHA class II–IV. • Presence of ≥1 of the following: – Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at screening – Hospitalisation for heart failure within previous 12 months prior to screening. • Preserved ejection fraction, defined as LVEF > 40% (echocardiography) at screening per local reading and no prior measurement of LVEF ≤ 40% under stable conditions. • 6MWT distance of ≤ 350 m at screening and baseline. • Elevated NT‐proBNP (> 300 pg/mL for patients without atrial fibrillation; > 600 pg/mL for patients with atrial fibrillation). • If oral diuretics are prescribed to control symptoms, the dose must have been stable for ≥ 2 weeks prior to study entry.	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.

Key inclusion criteria

Key exclusion criteria

• Heart failure diagnosed ≥ 3 months before screening, and currently in NYHA class II–IV. • Presence of ≥1 of the following: – Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at screening – Hospitalisation for heart failure within previous 12 months prior to screening. • Preserved ejection fraction, defined as LVEF > 40% (echocardiography) at screening per local reading and no prior measurement of LVEF ≤ 40% under stable conditions. • 6MWT distance of ≤ 350 m at screening and baseline. • Elevated NT‐proBNP (> 300 pg/mL for patients without atrial fibrillation; > 600 pg/mL for patients with atrial fibrillation). • If oral diuretics are prescribed to control symptoms, the dose must have been stable for ≥ 2 weeks prior to study entry.

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.

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.