Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
NCT Number: NCT06535529
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Decompensated Heart Failure
Interventions: DRUG: Acetazolamide|DRUG: Dapagliflozin 10mg
Sponsor: Helwan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-24
Completion Date: 2025-09-01
Locations: Critical Care Medicine Department - Cairo University Hospitals., Cairo, Egypt

Summary:
The goal of this clinical trial is to compare the effectiveness of acetazolamide versus dapagliflozin as an add-on in treating acute decompensated heart failure (ADHF) in adult patients with clinical signs of volume overload requiring intravenous loop diuretics. It will also assess the safety of these drugs when added to standard care. The main questions it aims to answer are:

* Does acetazolamide or dapagliflozin lead to a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels?
* Which drug results in better loop diuretic efficiency, as measured by weight loss per 40 mg of intravenous furosemide or equivalent? We will compare acetazolamide to dapagliflozin, both added to standard intravenous loop diuretic therapy, to see which is more effective in decongesting patients with ADHF.

Participants will:

* Take either acetazolamide or dapagliflozin orally every day for 3 days
* Receive intravenous loop diuretics as part of standard care
* Undergo regular assessments of heart failure symptoms, weight, and laboratory tests
* Be followed up until hospital discharge and for 30 days after starting the study

Primary Outcome Measures: N-terminal pro-B-type natriuretic peptide (NT-proBNP), Absolute change in NT-proBNP levels from baseline to end of study period, From baseline to day 5 or intensive care unit (ICU) discharge, whichever occurs first|calculating of weight loss Loop diuretic efficiency, Weight loss (in kg) per 40 mg of intravenous furosemide or equivalent dose of other loop diuretics, 72 hours from initiation of treatment
Secondary Outcome Measures: Number of Participants with Successful decongestion, Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy (defined as doubling loop diuretic dose, addition of chlorthalidone, or ultrafiltration), 72 hours from initiation of treatment|Duration of the index hospital admission, Number of days from randomization until the date of discharge, From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 weeks|30-day mortality, Proportion of patients who die from any cause within 30 days of randomization, Up to 30 days|Cumulative dose of intravenous loop diuretics, Total milligrams of intravenous furosemide or equivalent dose of other loop diuretics administered, 5 days|Incidence of treatment-related metabolic acidosis, Proportion of patients developing metabolic acidosis requiring sodium bicarbonate (NaHCO3) supplementation, 5 days|percent of worsening renal failure (WRF), Proportion of patients experiencing either: a) An increase in serum creatinine \> 0.3 mg/dL from baseline, or b) A decrease in estimated glomerular filtration rate (eGFR) \> 20% from baseline, up to 4 weeks