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 |
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
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
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: +001 (617) 726-9554
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860 Peachwood Drive
DeLand, Florida 32720
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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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
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
Chiefland, Florida 32626
Phone: +001 (352) 490-4816
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Fort Worth, Texas 76107
Phone: +001 (817) 735-2054
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301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Phone: +001 (409) 772-9835
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Phone: +001 (904) 730-0101
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Jacksonville, Florida 32223
Phone: +001 (904) 854-1354
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4202 E Fowler Ave
Tampa, Florida 33620
Tampa, Florida 33620
(813) 974-2011
Phone: +001 (813) 259-8543
University of South Florida The University of South Florida is a high-impact, global research university...
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80 Jesse Hill Junior Drive Southeast
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Phone: +001 (404) 616-0121
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2401 Avenida Lainez
Bahia Blanca, 8000
Bahia Blanca, 8000
Phone: +54 291 4593600 ext360/307/362
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3000 Northwest Boca Raton Boulevard
Boca Raton, Florida 33431
Boca Raton, Florida 33431
Phone: +001 (561) 756-8206
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950 Stoneridge Drive
Bozeman, Montana 59718
Bozeman, Montana 59718
Phone: +001 (406) 585-2444
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1461 Astor Avenue
Bronx, New York 10469
Bronx, New York 10469
Phone: +001 (718) 655-1060
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1234 Huffman Mill Road
Burlington, North Carolina 27215
Burlington, North Carolina 27215
Phone: +001 (336) 538-2381
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1720 East Hundred Road
Chester, Virginia 23836
Chester, Virginia 23836
Phone: +001 (804) 530-5178
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Cleveland, Ohio 44106
Phone: +001 (216) 421-3098
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10710 Charter Drive
Columbia, Maryland 21044
Columbia, Maryland 21044
Phone: +001 (443) 531-1400
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1801 Inwood Rd
Dallas, Texas 75390
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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Elkhart, Indiana 46541
Phone: +001 (574) 522-0337
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780 Main Street
Great Barrington, Massachusetts 01230
Great Barrington, Massachusetts 01230
Phone: +001 (561) 756-8206
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5330 East Stop 11 Road
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Phone: +001 (317) 893-1712
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327 Summar Drive
Jackson, Tennessee 38301
Jackson, Tennessee 38301
Phone: +001 (731) 423-8200
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Johnstown, Pennsylvania 15905
Phone: +001 (814) 410-1250
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4401 Wornall Rd
Kansas City, Missouri 64111
Kansas City, Missouri 64111
(816) 932-2000
Phone: +001 (816) 932-5478
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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5565 Grossmont Center Drive
La Mesa, California 91492
La Mesa, California 91492
Phone: +001 (619) 462-9353
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8860 Center Drive
La Mesa, California 91942
La Mesa, California 91942
Phone: +001 (619) 229-1995
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6420 Dutchmans Parkway
Louisville, Kentucky 40205
Louisville, Kentucky 40205
Phone: +001 (502) 891-8300
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424 East Yosemite Avenue
Merced, California 95340
Merced, California 95340
Phone: +001 (209) 723-6882
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1983 Marcus Avenue
New Hyde Park, New York 11042
New Hyde Park, New York 11042
Phone: +001 (516) 627-2121
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5200 East Interstate 240 Service Road
Oklahoma City, Oklahoma 73135
Oklahoma City, Oklahoma 73135
Phone: +001 (405) 628-6865
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416 Connable Avenue
Petoskey, Michigan 49770
Petoskey, Michigan 49770
Phone: +001 (231) 487-9185
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401 North 11th Street
Richmond, Virginia 23219
Richmond, Virginia 23219
Phone: +001 (804) 828-2161
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234-36 Merrick Boulevard
Rosedale, New York 11422
Rosedale, New York 11422
Phone: +001 (718) 949-9400
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1970 Roanoke Boulevard
Salem, Virginia 24153
Salem, Virginia 24153
Phone: +001 (540) 982-2463-x2970
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