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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:March 2, 2017
End Date:June 1, 2021
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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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


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
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Inverness, Florida 34452
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Chapel Hill, North Carolina 27599
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5801 South Ellis Avenue
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