Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

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