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
We found this trial at
82
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: +001 (214) 645-2727
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Phone: +001 (386) 785-2400
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Phone: +001 (617) 636-6049
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: +001 (919) 843-5223
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: +001 (773) 702-9396
University of Chicago One of the world's premier academic and research institutions, the University of...
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Phone: +001 (904) 730-0101
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
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24 Sturtevant St
Orlando, Florida 32806
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Alexandria, Louisiana 71301
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1501 West Chisholm Street
Alpena, Michigan 49707
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800 North Fant Street
Anderson, South Carolina 29621
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Annapolis, Maryland 21401
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Arlington Heights, Illinois 60005
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Asheville, North Carolina 28802
Phone: +001 (828) 274-6001-x48463
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80 Jesse Hill Junior Drive Southeast
Atlanta, Georgia 30303
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Augusta, Georgia 30912
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Aurora, Colorado 80012
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2401 Avenida Lainez
Bahia Blanca, 8000
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Baltimore, Maryland 21218
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Beltsville, Maryland 20705
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1461 Astor Avenue
Bronx, New York 10469
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1234 Huffman Mill Road
Burlington, North Carolina 27215
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Charleston, South Carolina 29403
Phone: +001 (843) 792-1414
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Charlotte, North Carolina 28204
Phone: +001 (704) 264-1400
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3091 William Street
Cheektowaga, New York 14227
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1720 East Hundred Road
Chester, Virginia 23836
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3001 Green Bay Road
Chicago, Illinois 60088
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39 Starbrush Circle
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Dallas, Texas 75226
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Doylestown, Pennsylvania 18901
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: +001 (919) 862-5100
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Elizabethtown, Kentucky 42701
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Fort Lauderdale, Florida 33312
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780 Main Street
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5330 East Stop 11 Road
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Lawrenceville, Georgia 30046
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1040 Delaware Avenue
Marion, Ohio 43302
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Marshfield, Wisconsin 54449
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424 East Yosemite Avenue
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Miami, Florida 33173
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1787 Madison Avenue
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1100 Reid Parkway
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Saint Louis, Missouri 63110
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1970 Roanoke Boulevard
Salem, Virginia 24153
Phone: +001 (540) 982-2463-x2970
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Phone: +001 (941) 917-6164
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Savannah, Georgia 31406
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South Bend, Indiana 46601
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97 North Sea Road
Southampton, New York 11968
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Phone: +001 (631) 444-8258
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Tampa, Florida 33613
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
Phone: +001 (419) 383-3697
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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21732 South Vermont Avenue
Torrance, California 90502
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