Table 1.
Inclusion/exclusion criteria | EMPEROR-reduced trial | EMPEROR-preserved trial |
---|---|---|
Inclusion criteria |
• Aged ≥ 18 years • Patients with chronic heart failure (≥ 3 months), NYHA class II-IV and reduced LVEF ≤ 40% with elevated NT-proBNP: - If EF = 36–40%: NT-proBNP ≥ 2500 pg/ml for patients without AF; NT-proBNP ≥ 5000 pg/ml for patients with AF - If EF = 31–35%: NT-proBNP ≥ 1000 pg/ml for patients without AF; NT-proBNP ≥ 2000 pg/ml for patients with AF - If EF ≤ 30%: NT-proBNP ≥ 600 pg/ml for patients without AF; NT-proBNP ≥ 1200 pg/ml for patients with AF - If EF ≤ 40% and HHF < 12 months: NTproBNP ≥ 600 pg/ml for patients without AF; NT-proBNP ≥ 1200 pg/ml with AF • Appropriate medical therapy for HF, stable for at least 1 week • Appropriate use of medical devices, such as ICD or CRT |
• Aged ≥ 18 years • Patients with chronic heart failure (≥ 3 months), NYHA class II-IV and preserved LVEF > 40% with elevated NT-proBNP: - NT-proBNP > 300 pg/ml for patients without AF - NT-proBNP > 900 pg/ml for patients with AF • Structural heart disease within 6 months prior, or documented HHF within 12 months prior to Visit 1 • Stable dose of oral diuretics, if prescribed |
Exclusion criteria (same in both trials) |
• Myocardial infarction, CABG or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1 • Heart transplant recipient, or listed for heart transplant • Acute decompensated HF • Systolic blood pressure (SBP) ≥ 180 mmHg, symptomatic hypotension and/or SBP ≤ 100 mmHg • Indication of liver disease • eGFR < 20 ml/min/1.73 m2 or requiring dialysis • History of ketoacidosis • Current use or prior use of a SGLT-2 inhibitor • Currently enrolled in an investigational device or drug study • Known hypersensitivity to empagliflozin or SGLT-2 inhibitor • Women who are pregnant, or who plan to become pregnant |
AF Atrial fibrillation/atrial flutter,CABG coronary artery bypass graft, CRT cardiac resynchronisation device, EF ejection fraction, eGFR estimated glomerular filtration rate, HF heart failure, HHF hospitalisation for heart failure, ICD implantable cardiac defibrillator, LVEF left ventricular ejection fraction, NT-proBNP N-terminal of the prohormone brain natriuretic peptide, NYHA New York Heart Association Classification, SGLT-2 sodium-glucose co-transporter-2, TIA transient ischaemic attack,