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.

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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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

263

Study ID:

NCT02653482

Recruitment Status:

Completed

Sponsor:

Saint Luke's Health System

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There are 25 Locations for this study

See Locations Near You

Heart Group of the Eastern Shore
Fairhope Alabama, 36532, United States
University of Southern Califiornia
Los Angeles California, 90032, United States
First Coast Cardiovascular Institute
Jacksonville Florida, 32256, United States
Charlotte Heart Group Research Center
Port Charlotte Florida, 33952, United States
Emory University
Atlanta Georgia, 30303, United States
NorthShore University HealthSystem Research Institute
Evanston Illinois, 60201, United States
Northwestern University
Evanston Illinois, 60208, United States
Advocate Health and Hospitals
Oakbrook Terrace Illinois, 60181, United States
University of Maryland
Baltimore Maryland, 21201, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Freeman Health System
Joplin Missouri, 64804, United States
Truman Medical Center
Kansas City Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Washington University
Saint Louis Missouri, 63110, United States
New York University
New York New York, 10016, United States
St. Francis Hospital
Roslyn New York, 11576, United States
Duke University
Durham North Carolina, 27705, United States
Eastern Nephrology Associates
New Bern North Carolina, 28562, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19106, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
University of Texas Southwestern
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

263

Study ID:

NCT02653482

Recruitment Status:

Completed

Sponsor:


Saint Luke's Health System

How clear is this clinincal trial information?

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