Dapagliflozin at Discharge on Hospital Heart Failure Readmission

This is an interventional treatment trial for Heart Failure focused on measuring hospitalization, mortality, time of initiation of therapy, quality of life, cost-effectiveness, dapagliflozin, clinical trial, diabetes Read More

Inclusion Criteria:

1. Males or females between the ages of 18 and 90 years, with ADHF, and New York Heart Association (NYHA) class II, III, or IV symptoms discharged after hospital admission with a clinical diagnosis ADHF
2. Elevated NT-pro-BNP ≥300 pg/ml or BNP (≥100 pg/ml) on admission
3. Interpretable echocardiogram during hospital admission (or within 12 months prior to index hospitalization)
4. Blood glucose level <400 mg/dL without evidence of diabetic ketoacidosis (serum bicarbonate <18 milliequivalent (mEq)/L or positive serum or urinary ketones), in patients with T2D

Exclusion Criteria:

1. Age < 18 or > 90 years
2. Subjects with a history of type 1 diabetes
3. Treatment with thiazolidinediones (TZDs) or SGLT2-i during the past 3 months of admission
4. Recurrent episodes of severe hypoglycemia or hypoglycemic unawareness
5. History of recurrent HF admissions considered to be due to non-compliance (evaluated by the research staff for participation)
6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 times upper limit of normal
7. Patients with impaired renal function (GFR < 25 ml/min)
8. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
9. Patients on ventricular assist devices (VADs)
10. History of heart transplant or listed for heart transplant
11. History of cardiac surgery (within 90 days prior to enrollment) or planned cardiac interventions within the following 6 months, including percutaneous coronary intervention (PCI), ablation, cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD)
12. HF due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valvular diseases, hypertrophic cardiomyopathy, or congenital heart disease
13. History of SGLT2-i allergy
14. Systolic blood pressure < 100 mmHg
15. Uncontrolled hypertension, defined as a systolic blood pressure > 200 mmHg at randomization
16. Female subjects who are pregnant or breast-feeding at time of enrollment into the study
17. Females of childbearing potential who are not using adequate contraceptive methods
18. In hospice or expected life expectancy less than 6 months
19. Patients with diabetic foot infection, osteomyelitis and history of amputation of lower extremities within 6 months of admission
20. Patients anticipated to undergo major surgical procedures during the following 6 months
21. Patients with active hematuria, urinary tract infection (UTI), or history of frequent UTIs or genital mycotic infections
22. Uncontrolled atrial fibrillation or atrial flutter with a resting heart rate >110bpm documented by ECG at randomization
23. Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWD
24. Chronic pulmonary disease, i.e. with known forced expiratory volume in the first second (FEV1) <50% requiring home oxygen, or oral steroid therapy or current hospitalization for severe chronic obstructive pulmonary disease (COPD) thought to be a primary contributor to dyspnea, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
25. Patients with active history of bladder cancer
26. Patients with previous history of diabetic ketoacidosis, per American Diabetes Association (ADA) criteria