Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

About this trial

This study investigates the comparative clinical outcomes of dapagliflozin, an SGLT-2 inhibitor, versus acetazolamide, a carbonic anhydrase inhibitor, in patients hospitalized with acute heart failure (AHF). The trial aims to assess the effectiveness of these drugs in improving natriuretic and diuretic responses and shortening hospital stays. Dapagliflozin and acetazolamide will be added to standard loop diuretic therapy, and their safety profiles will be evaluated to identify potential side effects. This research seeks to provide evidence for incorporating these drugs into AHF management, with the potential to improve clinical outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure > 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound. OR

If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above.

Randomized within 24 hours of hospitalization for AHF.

Planned use of IV loop diuretic therapy during current hospitalization

Disqualifiers

Unable to follow instructions.

Treated with any proximal tubular diuretics.

Systolic blood pressure of less than 90 mm Hg.

An estimated glomerular filtration rate (GFR) of less than 20 ml per 1.73 m2 of body-surface area.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10mg

    Drug

    Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.

  • Acetazolamide 500mg

    Drug

    Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dapagliflozin 10mgExperimental treatment 1 intervention
Group B: Acetazolamide 500mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in dyspnea VAS (Visual analogue scale)

Comparing the area under the curve (AUC) of change in VAS dyspnea score. To do so, individual changes in VAS score will be visualized as a curve where the x-axis shows study day baseline to day 3, and y-axis shows VAS score. Using this approach, AUC for each study day will be calculated, and added together, resulting in an overall VAS AUC score (mm × h) that can be compared across treatment groups.

Time frame
From baseline to day 3

Secondary outcomes

Other outcomes

Sponsors and contacts

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