SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF
NCT06442280 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 544
Last updated 2024-06-06
Summary
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.
Conditions
- Heart Failure Acute
- Diabetes Type 2
- Heart Failure With Reduced Ejection Fraction
- Heart Failure With Preserved Ejection Fraction
Interventions
- DRUG
-
Dapagliflozin tablet
Dapagliflozin 10 mg 1 tablet once daily
- DRUG
-
Hypertonic Saline Solution, 1 Ml
Intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily
- DRUG
-
Furosemide Injection
Furosemide 20 mg
Sponsors & Collaborators
-
University of Palermo
lead OTHER
Principal Investigators
-
Giuseppe Miceli, PhD · A.O.U.P. Paolo Giaccone Palermo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-30
- Primary Completion
- 2026-01-31
- Completion
- 2026-03-30
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