Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - 119
Updated:4/6/2019
Start Date:March 3, 2016
End Date:June 2019

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The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared
with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and
quality of life in patients with chronic heart failure with reduced systolic function.

A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of
once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (BNP and
NTproBNP), symptoms, health status, and quality of life in patients with chronic heart
failure with reduced systolic function.

Inclusion Criteria:

1. Established diagnosis of NYHA Class II or Class III heart failure (LVEF≤40% due to
either ischemic or non-ischemic etiology) with reduced systolic function for at least
16 weeks prior to enrollment

2. No change in diuretic management for at least 1 week prior to enrollment

3. BNP ≥100 pg/mL and/or NTproBNP ≥ 400 pg/mL at enrollment

Exclusion Criteria:

1. History of type 1 diabetes

2. Estimated glomerular filtration rate (eGFR) < 30 at enrollment

3. Hospitalization for heart failure within the 30 days prior to enrollment

4. Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or
unstable angina), percutaneous coronary intervention, or cardiac surgery within the 30
days prior to enrollment

5. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the
screening visit

6. Planned cardiovascular revascularization (percutaneous intervention or surgical) or
major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular
assist device, cardiac transplantation, or any other surgery requiring thoracotomy)
within the 90 days after enrollment

7. Patients who are volume depleted based upon physical examination at the time of
screening or randomization
We found this trial at
23
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New Bern, North Carolina 28562
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-616-3719
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Durham, North Carolina 27710
(919) 684-8111
Phone: 919-970-8924
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-7635
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Dallas, Texas 75390
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Detroit, Michigan 48202
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Evanston, Illinois 60208
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Fairhope, Alabama 36532
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Jacksonville, Florida 32216
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Jacksonville, FL
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1102 W 32nd St
Joplin, Missouri 64804
(417) 347-1111
Phone: 417-347-3493
Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
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2301 Holmes
Kansas City, Missouri 64108
816-404-1000
Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Phone: 816-932-5989
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Los Angeles, California 90032
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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70 Washington Square S
New York, New York 10012
(212) 998-1212
Phone: 646-501-2897
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Oakbrook Terrace, Illinois 60181
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-662-4214
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Port Charlotte, Florida
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Roslyn, New York 11576
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Saint Louis, Missouri 63110
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