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RecruitingNCT06783166Updated Jan 20, 2025

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

A Phase 2/3 interventional study of Dapagliflozin 10mg and Acetazolamide 500mg in Acute Heart Failure, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by Mansoura University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Aug 2024, registered Jan 2025).
  • Started Aug 2024; still recruiting 2 years 1 month later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Heart Failure

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03

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:

    • 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.
  2. Randomized within 24 hours of hospitalization for AHF.
  3. Planned use of IV loop diuretic therapy during current hospitalization
  4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation.

Exclusion criteria

Exclusion Criteria:

  1. Unable to follow instructions.
  2. Treated with any proximal tubular diuretics.
  3. Systolic blood pressure of less than 90 mm Hg.
  4. An estimated glomerular filtration rate (GFR) of less than 20 ml per 1.73 m2 of body-surface area.
  5. Type 1 diabetes mellitus.
  6. Dyspnea is primarily due to non-cardiac causes.
  7. Cardiogenic shock.
  8. Acute coronary syndrome within 30 days prior to randomization.
  9. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
  10. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L).
  11. Pregnant or nursing (lactating) women.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Dapagliflozin 10mg

    Patients will receive once daily dapagliflozin 10 mg orally in addition to loop diuretic therapy and standard care for 3 days.

    Drug: Dapagliflozin 10mg

  • Active comparator
    Acetazolamide 500mg

    Patients will receive once daily acetazolamide 500 mg orally in addition to loop diuretic therapy and standard care for 3 days.

    Drug: Acetazolamide 500mg

Interventions

  • DrugDapagliflozin 10mg

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

  • DrugAcetazolamide 500mg

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Noha Mansour
    Mansoura, 35516, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06783166
Lead sponsor
Mansoura University
Responsible party
Noha Mansour (Lecturer of Clinical Pharmacy, Mansoura University) — Principal investigator
First posted
Jan 20, 2025
Start date
Aug 15, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Jan 20, 2025

Study contacts

Hossameldin Sharaf, BSc
Contact
hossamsharaaf@gmail.com
+201009648197
Noha Mansour, PhD
principal investigator · Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
Moheb Magdy Mouris, MD
principal investigator · Department of Cardiology, Faculty of Medicine, University of Mansoura
Mohamed El- Husseiny Shams, Professor
study chair · Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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