EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Empagliflozin; Placebo
Intervention description: once daily; once daily
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5988.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study in adults with chronic heart failure. People with chronic heart failure may
      need to be hospitalised for their condition. Some people with chronic heart failure may
      eventually die from their condition. The purpose of the study is to find out whether a
      medicine called empagliflozin lowers the chances of patients having to go to hospital for
      heart failure and whether it improves their survival. The study is open to patients with a
      type of chronic heart failure called chronic heart failure with preserved ejection fraction.

      Participants stay in the study until researchers have enough information about how effective
      empagliflozin is. It is expected that participants who enter at the very beginning of the
      enrolment period may be in the study for over 3 years, while participants who enter near the
      end of the enrolment period may be in the study for less than 2 years. The participants are
      put into 2 groups. It is decided by chance who gets into which group. One group gets
      empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo
      tablets look like empagliflozin tablets but contain no medicine.

      Participants visit the doctors regularly. During these visits, the doctors collect
      information about the participant's health. The doctors want to know how many patients had to
      go to hospital because of heart failure or who died from cardiovascular disease.
    

Eligibility criteria:

        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 preserved EF (Ejection Fraction)(LVEF (Left
             Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the
             prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900
             pg/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 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 (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) < 20
             mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration
             Equation))cr 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 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