Heart Failure Clinical Trial
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart failure (left ventricular ejection fraction ≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment
No change in diuretic management for at least 1 week prior to enrollment
Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment
Exclusion Criteria:
History of type 1 diabetes
Estimated glomerular filtration rate (eGFR) < 30 at enrollment
Hospitalization for heart failure within the 30 days prior to enrollment
Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within the 30 days prior to enrollment
Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
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
Patients who are volume depleted based upon physical examination at the time of screening or randomization
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There are 25 Locations for this study
Fairhope Alabama, 36532, United States
Los Angeles California, 90032, United States
Jacksonville Florida, 32256, United States
Port Charlotte Florida, 33952, United States
Atlanta Georgia, 30303, United States
Evanston Illinois, 60201, United States
Evanston Illinois, 60208, United States
Oakbrook Terrace Illinois, 60181, United States
Baltimore Maryland, 21201, United States
Bethesda Maryland, 20889, United States
Boston Massachusetts, 02115, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Joplin Missouri, 64804, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
Roslyn New York, 11576, United States
Durham North Carolina, 27705, United States
New Bern North Carolina, 28562, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19106, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
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