Enhanced Diuresis and Natriuresis in Acute Decompensated Heart Failure Patients Treated With SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution: A Clinical Trial

UPalermo7

The purpose of the current investigation is to demonstrate the efficacy of high-dose furosemide plus small-volume hypertonic saline solution and a Sodium-Glucose cotransporter-2 (SGLT-2) inhibitor among patients admitted for acute exacerbation of heart failure, in determining a significant increase in diuresis and natriuresis. It is also accompanied by a rapid reduction in body weight and a substantial decrease in hospitalization length without compromising renal function.

2024-06-01

2026-01-31

2026-03-30

Not yet recruiting

Early phase I

544

Inclusion Criteria: * acute heart failure; * diabetes type 2. Exclusion Criteria: * low estimated glomerular filtration rate; * hypernatremia; * diabetes type 1; * non-cardiac causes of dyspnea; * cardiogenic shock; * recent occurrence of Acute Coronary Syndrome; * ketoacidosis; * hyperosmolar hyperglycemic syndrome.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be categorized into 4 groups: the first group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solution (100 mL) twice daily along with severe water restriction (\\< 500 mL); the second group will receive intravenous furosemide as a bolus twice daily and severe water restriction (\\< 500 mL) without hypertonic saline solution; the third group will undergo 15 minutes intravenous infusion of furosemide combined with hypertonic saline solution (100 mL) twice daily, severe water restriction (\\< 500 mL), and SGLT2 inhibitors (Dapagliflozin); the fourth group will receive intravenous furosemide as a bolus without hypertonic saline solution twice daily, severe water restriction (\\< 500 mL), and SGLT2 inhibitors (Dapagliflozin).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 544, 'type': 'ESTIMATED'}}

2024-06-06