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

Inclusion criteria:

• Male or female patient, age >= 18 years at screening. For Japan only: Age >=20 yearsat screening
• Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Associationclassification) class II-IV and preserved EF (Ejection Fraction)(LVEF (LeftVentricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of theprohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
• Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
• Stable dose of oral diuretics, if prescribed
• Signed and dated written ICF (informed consent form)
• Further inclusion criteria apply

Exclusion criteria:

• Myocardial infarction, coronary artery bypass graft surgery or other majorcardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 daysprior to Visit 1
• Heart transplant recipient or listed for heart transplant
• Acute decompensated HF (Heart Failure)
• 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) < 20mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology CollaborationEquation))cr or requiring dialysis
• History of ketoacidosis
• Current use or prior use of a SGLT (Sodium-glucose co-transporter) -2 inhibitor orcombined SGLT-1 and 2 inhibitor
• Currently enrolled in another investigational device or drug trial
• 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 may apply