Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients

Sponsor
Helwan University
Study ID
NCT06535529
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Decompensated Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acetazolamide — DRUG
    Patients will receive acetazolamide 500 mg once daily for 3 days as add on therapy to IV loop diuretics
  • Dapagliflozin 10mg — DRUG
    patient will receive oral dapagliflozin 10 mg once daily for 3 days as add on therapy to IV loop diuretics

Study Details

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

Key Dates

Start date
Aug 24, 2024
Status verified
Aug 2024
Primary completion
Aug 1, 2025
Completion
Sep 1, 2025

Study Design

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

Arms

  • Active Comparator: Acetazolamide + Standard Care
    Participants in this arm will receive: 1. Acetazolamide: 500 mg orally, once daily for 3 days 2. Intravenous loop diuretics: Administered at double the oral maintenance dose, given as follows: * Initial dose: Single bolus immediately after randomization * Subsequent doses: Split into two or more doses (separated by ≥6 hours) on each of the next 2 days The specific loop diuretic used (e.g., furosemide) will be determined by the treating physician based on the patient's prior medication regimen and clinical status.
  • Active Comparator: Dapagliflozin + Standard Care
    Participants in this arm will receive: 1. Dapagliflozin: 10 mg orally, once daily for 3 days 2. Intravenous loop diuretics: Administered as described in Arm 1

Primary Outcome Measure

N-terminal pro-B-type natriuretic peptide (NT-proBNP) [ Time Frame: From baseline to day 5 or intensive care unit (ICU) discharge, whichever occurs first ]

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