Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Heart Failure With Reduced Systolic Function

In brief

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.

Key facts

Study ID

NCT02653482

Run by

Saint Luke's Health System

People needed

263

Starts

2016-03-03

Expected to finish

2019-06-28

Last updated by the study team

2022-04-21

Who can join

Age: 19 and older, up to 119. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Heart Group of the Eastern Shore — Fairhope, Alabama, United States
• University of Southern Califiornia — Los Angeles, California, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Charlotte Heart Group Research Center — Port Charlotte, Florida, United States
• Emory University — Atlanta, Georgia, United States
• NorthShore University HealthSystem Research Institute — Evanston, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• Advocate Health and Hospitals — Oakbrook Terrace, Illinois, United States
• University of Maryland — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Freeman Health System — Joplin, Missouri, United States
• Truman Medical Center — Kansas City, Missouri, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• New York University — New York, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Duke University — Durham, North Carolina, United States
• Eastern Nephrology Associates — New Bern, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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