Efficacy and Safety of Dapagliflozin in Acute Heart Failure (DICTATE-AHF)
Heart Failure, Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Age of 18 years or older
Randomized within 24 of presentation during a hospital admission for hypervolemic decompensated heart failure defined as:
- pulmonary artery catheterization with a pulmonary capillary wedge pressure greater than 19mmHg plus a systemic physical exam finding of hypervolemia (peripheral edema, ascites, or pulmonary edema on auscultation)
- in the absence of pulmonary artery catheterization data 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure > 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound
- Planned use of IV loop diuretic therapy during current hospitalization
- eGFR of 25 ml/min/1.73m2 by the MDRD equation or greater
Exclusion Criteria:
- Type 1 diabetes
- Serum glucose < 80mg/dl at enrollment
- Systolic blood pressure < 90mmHg at enrollment
- Requirement of intravenous inotropic therapy
- History of hypersensitivity to any SGLT2 inhibitors
- Women who are pregnant or breastfeeding
- Severe anemia (Hemoglobin < 7.5g/dl)
- Severe uncorrected aortic or mitral stenosis
- Inability to perform standing weights or measure urine output accurately
- History of diabetic ketoacidosis
- Scheduled combination nephron blockade with loop and thiazide therapy as an outpatient
- Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 40-pounds
- Severe hepatic impairment (Child-Pugh class C)
Sites / Locations
- University of Mississippi Medical Center
- University of North Carolina
- INTEGRIS
- TriStar Centennial Medical Center
- Saint Thomas West Hospital
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Protocolized diuretic therapy
Protocolized diuretic therapy plus SGLT2 inhibitor therapy
The patients with diabetes will receive standard of care point of care blood glucose monitoring 4 times daily (before meals and at bedtime) and sliding scale insulin. The initial loop diuretic regimen after enrollment: Loop diuretic naïve: If the patient does not take a scheduled loop diuretic as an outpatient, the initial IV loop diuretic dose will be 40mg of furosemide equivalents every 12 hours. Chronic, oral loop diuretic therapy: If the patient takes a scheduled loop diuretic regimen as an outpatient prior to hospital admission, the initial IV loop diuretic daily dose will be 2 times the total daily home regimen dose. Diuretic therapy will be titrated to goal urine output using a standardized diuretic protocol.
The patients with diabetes will receive standard of care point of care blood glucose monitoring 4 times daily (before meals and at bedtime) and sliding scale insulin. The initial loop diuretic regimen after enrollment: Loop diuretic naïve: If the patient does not take a scheduled loop diuretic as an outpatient, the initial IV loop diuretic dose will be 40mg of furosemide equivalents every 12 hours. Chronic, oral loop diuretic therapy: If the patient takes a scheduled loop diuretic regimen as an outpatient prior to hospital admission, the initial IV loop diuretic daily dose will be 2 times the total daily home regimen dose. Diuretic therapy will be titrated to goal urine output using a standardized diuretic protocol. The patient will receive SGLT2 inhibitor therapy with dapagliflozin 10 mg orally once daily until 5 days or hospital discharge.