Acute decompensated heart failure with hyponatremia patients SGLT2 inhibitors, acute heart failure, hyponatremia, empagliflozin
Conditions
Interventions
Empagliflozin 10 mg for 5 days,Placebo for 5 days
Experimental Drug,Placebo Comparator Drug
Empagliflozin 10 mg,Placebo
Sponsors
Thammasat University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged more than 18 years who were hospitalized for acute HF according to ESC guideline 2021 guideline 2. estimated glomerular filtration rate more than 20mL/min/1.73m2 3. Hyponatremia, Na < 135 mEq/L 4. N-terminal pro BNP > 450 pg/mL
Exclusion criteria
Exclusion criteria: 1. Sign of shock or septic shock (systolic blood pressure <90 mm Hg; signs of hypoperfusion [altered mental status, cold skin, diuresis <30 mL/h, and blood lactate >2.0 mmol/L]) 2. Severe symptomatic hyponatremia in need of treatment with 3% NaCl 3. Patients requiring mechanical ventilation or receiving intravenous inotropes or vasopressors 4. Type 1 diabetes mellitus 5. Urinary tract infection included acute pyelonephritis, acute cystitis, Fournier gangrene 6. Diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome 7. Hypoglycemia ,serum glucose level < 55 mg/dL 8. SGLT2 inhibitor use in the previous 4 weeks before admission 9. Chronic kidney disease with estimated glomerular filtrate rate (eGFR) <20 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration) 10. Acute kidney injury AKIN stage more than 2 or requiring RRT 11. Individual SGLT2i intolerance 12. Advance Cirrhosis CTP C 13. Mental illness (inability to sign an informed consent form; lack of comprehension of the possible consequences) 14. Pregnant or breastfeeding patients 15. Treatment with SGLT2 inhibitors or Tolvaptans 16. Treatment with an immunosuppressive drug, such as prednisolone at a dose 45 mg or an equivalence dose of another corticosteroids) 17. Patient with advance palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of serum sodium levels at 120 hours 120 hours serum sodium levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of serum sodium levels at 48 h 48 hours serum sodium levels,Urine output at 120 hours 120 hours Urine output in mL,eGFR change at 120 hours 120 hours eGFR ,creatinine change at 120 hours 120 hours serum creatinine,eGFR change at 48 hours 48 hours eGFR,serum creatinine change at 48 hours 48 hours serum creatinine,Adverse event 120 hours Adverse event,Change of serum sodium at 30 days 30 days serum sodium | — |
Countries
Thailand
Contacts
Public ContactPeerapat Thanapongsatorn
Thammasat University Hospital
Outcome results
None listed