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

  • Interventional
  • Recruiting
  • NCT03057951
Eligibility Details Visit Clinicaltrials.gov

A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction


Age Group
18 Years and up

Accepting Healthy Volunteers?

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

At a Glance

National Government IDNCT03057951


Lead SponsorBoehringer Ingelheim

Lead PhysicianGabriel T. Sayer


18 Years and up