EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

Inclusion criteria:

- Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years
at screening

- Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association
Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular
Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain
natriuretic peptide)

- If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial
fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF

- If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and
NT-proBNP >=2000 pg/ml for patients with AF

- If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200
pg/ml for patients with AF

- EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥
600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with
AF

- Appropriate dose of medical therapy for HF consistent with prevailing local and
international CV (Cardiovascular) guidelines, stable for at least 1 week prior to
Visit 1

- Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a
cardiac resynchronization therapy (CRT) consistent with prevailing local or
international CV guidelines

- Signed and dated written ICF (Informed Consent Form)

- Further inclusion criteria apply

Exclusion criteria:

- Myocardial infarction, coronary artery bypass graft surgery, or other major
cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) 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 at Visit 2.

- Symptomatic hypotension and/or a SBP < 100 mmHg

- Indication of liver disease

- Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20
mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration
Equation)) or requiring dialysis

- History of ketoacidosis

- Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or
combined SGLT-1 and 2 inhibitor

- Currently enrolled in another investigational device or drug study

- Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors

- Women who are pregnant, nursing, or who plan to become pregnant while in the trial

- Further exclusion criteria apply