Acute Heart FailurePhase 2/3NCT06783166
Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure
A Phase 2/3 study testing Dapagliflozin 10mg and Acetazolamide 500mg in people with Acute Heart Failure, run by Mansoura University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Dapagliflozin 10mg and Acetazolamide 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 5 Aug 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Randomized within 24 hours of hospitalization for AHF.
- Planned use of IV loop diuretic therapy during current hospitalization
- Estimated glomerular filtration rate (eGFR) of at least 25 ml/min/1.73m2 by the MDRD equation.
Who cannot join
- 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 25 ml per 1.73 m2 of body-surface area.
- Type 1 diabetes mellitus.
- Dyspnea is primarily due to non-cardiac causes.
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- Cardiogenic shock.
- Acute coronary syndrome within 30 days prior to randomization.
- Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
- Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L).
- Pregnant or nursing (lactating) women.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Heart Failure
- Being tested
- Dapagliflozin 10mg, Acetazolamide 500mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mgDrug
Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Acetazolamide 500mgDrug
Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg | Experimental | Patients will receive once daily dapagliflozin 10 mg orally in addition to loop diuretic therapy and standard care for 3 days. Receives: Drug: Dapagliflozin 10mg |
| Acetazolamide 500mg | Active comparator | Patients will receive once daily acetazolamide 500 mg orally in addition to loop diuretic therapy and standard care for 3 days. Receives: Drug: Acetazolamide 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Aug 2024
- Primary completion4 Jul 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
- Investigators
- Noha Mansour, PhD, Principal investigator, Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of MansouraMoheb Magdy Mouris, MD, Principal investigator, Department of Cardiology, Faculty of Medicine, University of MansouraMohamed El- Husseiny Shams, Professor, Study chair, Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783166
- Sponsor's protocol ID
- MS.24.04.2757
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sharaf H, Wadie M, Mansour NO, Shams MEE. Dapagliflozin vs. Acetazolamide in Patients With Acute Heart Failure: A Randomized Controlled Trial (CHOICE-AHF). Clin Pharmacol Ther. 2026 Nov 3. doi: 10.1002/cpt.70540. Online ahead of print.
PubMed 42977703
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT06783166
- Acronym / sponsor ID
- MS.24.04.2757
- Conditions
- Acute Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg | Experimental | Drug: Dapagliflozin 10mgPatients will receive once daily dapagliflozin 10 mg orally in addition to loop diuretic therapy and standard care for 3 days. |
| Acetazolamide 500mg | Active comparator | Drug: Acetazolamide 500mgPatients will receive once daily acetazolamide 500 mg orally in addition to loop diuretic therapy and standard care for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:
- Randomized within 24 hours of hospitalization for AHF.
- Planned use of IV loop diuretic therapy during current hospitalization
- Estimated glomerular filtration rate (eGFR) of at least 25 ml/min/1.73m2 by the MDRD equation.
Key exclusion criteria (11 listed)
- 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 25 ml per 1.73 m2 of body-surface area.
- Type 1 diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mgDapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor. | Drug | Dapagliflozin 10mg |
| Acetazolamide 500mgAcetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor. | Drug | Acetazolamide 500mg |
Primary outcome
Change in dyspnea VAS (Visual analogue scale)
Time frame: From baseline to day 3
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 42977703Sharaf H, Wadie M, Mansour NO, Shams MEE. Dapagliflozin vs. Acetazolamide in Patients With Acute Heart Failure: A Randomized Controlled Trial (CHOICE-AHF). Clin Pharmacol Ther. 2026 Nov 3. doi: 10.1002/cpt.70540. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin 10mg and Acetazolamide 500mg in people with Acute Heart Failure, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dyspnea VAS (Visual analogue scale) (time frame: From baseline to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06783166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.