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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:March 6, 2017
End Date:June 1, 2020
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 Reduced Ejection Fraction (HFrEF)

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