This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:March 20, 2018
End Date:December 6, 2019
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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A Phase III Randomised, Double-blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Preserved Ejection Fraction (HFpEF) (EMPERIAL - Preserved)

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus
placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic
heart failure (CHF) with preserved ejection fraction (LVEF > 40%).

Secondary objectives are to assess Patient-Reported Outcome (PRO)


Inclusion Criteria:

- Of full age of consent (according to local legislation, usually ≥ 18 years) at
screening.

- Male or female patients. Women of child bearing potential (WOCBP) must be ready and
able to use highly effective methods of birth control per ICH M3 (R2) that result in a
low failure rate of less than 1% per year when used consistently and correctly. A list
of contraception methods meeting these criteria is provided in the patient
information.

- Signed and dated written informed consent in accordance with ICHGCP and local
legislation prior to admission to the trial

- Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.

- Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in
NYHA class II-IV

- Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left
ventricle ejection fraction(LVEF) > 40 % as per echocardiography at Visit 1 per local
reading and no prior measurement of LVEF ≤ 40% under stable conditions.

- Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/ml for patients
without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF, as analysed at
the Central laboratory at Visit 1

- Patients must have at least one of the following evidence of heart failure (HF):

- Structural heart disease (left atrial enlargement and/or left ventricular
hypertrophy) documented by echocardiogram at Visit 1, OR

- Documented Hospitalization for Heart Failure (HHF) within 12 months prior to
Visit 1

- Consistent with prevailing CV guidelines, if oral diuretics are prescribed to control
symptoms, patients must be on an appropriate and stable dose of oral diuretics for at
least 2 weeks prior to Visit 1 to control symptoms.

- Clinically stable at randomization with no signs of heart failure decompensation (as
per investigator judgement).

Exclusion Criteria:

- Myocardial infarction (increase in cardiac enzymes in combination with symptoms of
ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft
surgery or other major cardiovascular surgery, stroke or transient ischemic attack in
past 90 days prior to Visit 1

- Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics,
i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks
prior to Visit 1, and/or during screening period until Visit 2

- Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e.
studies 1245.110, 1245.121, 1245-0168)

- Type 1 Diabetes Mellitus (T1DM)

- Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring
dialysis, as determined at Visit 1

- Symptomatic hypotension or a systolic blood pressure (SBP) < 100 mmHg at Visit 1 or 2

- SBP ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2

- Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented
by ECG at Visit 1 (Screening)

- Unstable angina pectoris in past 30 days prior to Visit 1

- Largest distance walked in 6 minutes (6MWTD) at baseline <100m.

- Any presence of condition that precludes exercise testing such as:

- claudication,

- uncontrolled (according to investigator judgement) bradyarrhythmia or
tachyarrhythmia,

- significant musculoskeletal disease,

- primary pulmonary hypertension,

- severe obesity (body mass index ≥40.0 kg/m2),

- orthopedic conditions that limit the ability to walk (such as arthritis in the
leg, knee or hip injuries)

- amputation with artificial limb without stable prosthesis function for the past 3
months

- Any condition that in the opinion of the investigator would contraindicate the
assessment of 6MWT

- Patients in a structured (according to Investigator judgement) exercise training
program in the 1 month prior to screening or planned to start one during the course of
this trial.

- ICD implantation within 1 month prior to Visit 1 or planned during the course of the
trial

- Implanted cardiac resynchronisation therapy (CRT)

- Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to
screening.

- Further exclusion criteria applies
We found this trial at
42
sites
3801 South National Avenue
Springfield, Missouri 65807
Phone: +001 (417) 875-2718
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3420 Fannin
Beaumont, Texas 77701
409-813-1190
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: +001 (617) 667-8800
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Phone: +001 (601) 984-5678
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Albany, New York 12208
Phone: +001 (518) 626-6463
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Phone: +001 (404) 616-4440
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: +001 (303) 724-4651
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Boise, Idaho 83712
Phone: +001 (208) 388-7210
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Bossier City, Louisiana 71111
Phone: +001 (318) 752-2328
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Calgary, Alberta
Phone: 403-944-3232
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Columbia, South Carolina 29203
Phone: +001 (803) 256-6511-x3227
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24 Hospital Avenue
Danbury, Connecticut 06810
Phone: +001 (203) 739-7637
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Doral, Florida 33126
Phone: +001 (786) 631-3674
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2175 Charbonier Road
Florissant, Missouri 63031
Phone: +001 (314) 942-9978
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1001 Sam Perry Boulevard
Fredericksburg, Virginia 22401
Phone: +001 (540) 741-4655
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Gurnee, Illinois 60031
Phone: +001 (847) 599-2492-x103
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17800 Kedzie Avenue
Hazel Crest, Illinois 60429
Phone: +001 (708) 798-8522
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Huntington Beach, California 92648
Phone: +001 (714) 842-8100
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Jackson, Tennessee 38301
Phone: +001 (731) 422-0307
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Las Vegas, Nevada 89113
Phone: +001 (702) 851-7287-x356
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1040 Delaware Avenue
Marion, Ohio 43302
Phone: +001 (740) 383-7039
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Miami, Florida 33135
Phone: +001 (786) 360-4423
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4302 Alton Road
Miami Beach, Florida 33140
Phone: +001 (305) 335-8658
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Mobile, Alabama 36608
Phone: +001 (251) 433-4700
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New Brunswick, New Jersey 08903
Phone: +001 (732) 235-7829
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142 West York Street
Norfolk, Virginia 23510
Phone: +001 (757) 373-9478
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550 West 84th Street
North Miami Beach, Florida 33169
Phone: +001 (786) 703-5941
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Overland Park, Kansas 66209
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Palm Beach Gardens, Florida 33410
Phone: +001 (561) 775-1061
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Raleigh, North Carolina 27607
Phone: +001 (919) 784-3324
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Rapid City, South Dakota 57701
Phone: +001 (605) 755-4326
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Rocky Mount, North Carolina 27804
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Saint Augustine, Florida 32086
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Saraland, Alabama 36571
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Shreveport, Louisiana 71101
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Stockton, California 95204
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Sugar Land, Texas 77478
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3500 Lomita Boulevard
Torrance, California 90505
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1710 Watson Boulevard
Warner Robins, Georgia 31093
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West Monroe, Louisiana 71291
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Zephyrhills, Florida 33541
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