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Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients

ConditionAcute Decompensated Heart Failure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelwan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients of 18 years of age or older.

An elective or emergency hospital admission with clinical diagnosis of decompensated HF with at least one clinical sign of volume overload (e.g. edema, ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography).

Assessed LVEF by any imaging technique; i.e. echocardiography, catheterization, nuclear scan magnetic resonance imaging within 12 months of inclusion.

Disqualifiers

The receipt of acetazolamide maintenance therapy.

Receipt of an SGLT2 inhibitor in the 48 hours before randomization.

An estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2.

Use of any non-protocol defined diuretic agent with the exception of mineralocorticoid receptor antagonists during the treatment phase of the study. Thiazides, metolazone, indapamide and amiloride should be stopped upon study inclusion. If patient is taking a combination drug including a thiazide-type diuretic, the thiazide-type diuretic should be stopped.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Acetazolamide + Standard CareActive comparator 1 intervention
Group B: Dapagliflozin + Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

N-terminal pro-B-type natriuretic peptide (NT-proBNP)

Absolute change in NT-proBNP levels from baseline to end of study period

Time frame
From baseline to day 5 or intensive care unit (ICU) discharge, whichever occurs first
2

calculating of weight loss Loop diuretic efficiency

Weight loss (in kg) per 40 mg of intravenous furosemide or equivalent dose of other loop diuretics

Time frame
72 hours from initiation of treatment

Secondary outcomes

1

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)

Time frame
72 hours from initiation of treatment
2

Duration of the index hospital admission

Number of days from randomization until the date of discharge

Time frame
From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 weeks
3

30-day mortality

Proportion of patients who die from any cause within 30 days of randomization

Time frame
Up to 30 days
4

Cumulative dose of intravenous loop diuretics

Total milligrams of intravenous furosemide or equivalent dose of other loop diuretics administered

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helwan University

Lead sponsor

Source ClinicalTrials.gov
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