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
We found this trial at
118
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1501 West Chisholm Street
Alpena, Michigan 49707
Phone: +001 (989) 340-2091
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Phone: +001 (386) 785-2400
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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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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304 Northeast 1st Street
Chiefland, Florida 32626
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
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4085 University Blvd S # 1
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11701 San Jose Blvd # 32
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24 Sturtevant St
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Albany, New York 12208
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1801 Inwood Rd
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4401 Wornall Rd
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