SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF

Sponsor
University of Palermo
Study ID
NCT06442280
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin tablet — DRUG
    Dapagliflozin 10 mg 1 tablet once daily
  • Hypertonic Saline Solution, 1 Ml — DRUG
    Intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily
  • Furosemide Injection — DRUG
    Furosemide 20 mg

Study Details

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.

Key Dates

First listed
Jun 4, 2024
Start date
Jun 30, 2024
Status verified
Jun 2024
Primary completion
Jan 31, 2026
Completion
Mar 30, 2026

Study Design

Enrollment
544 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapa-Tonic
    This group will undergo a 15-minute intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin).
  • Placebo Comparator: Tonic-Placebo
    This group will undergo a 15-minute intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily along with severe water restriction (\< 500 mL).
  • Placebo Comparator: Furosemide-Placebo
    This group will undergo intravenous furosemide twice daily and severe water restriction (\< 500 mL) without hypertonic saline solutions.
  • Active Comparator: Dapa-Furo
    This group will undergo intravenous furosemide without hypertonic saline solutions twice daily, severe water restriction (\< 500 mL), and SGLT2 inhibitors (Dapagliflozin).

Primary Outcome Measure

Diuresis from the baseline and up to 1 week [ Time Frame: an average of 1 week ]

Central Contacts

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