Acute Decompensated Heart FailurePhase 2NCT07372040
Add-on Diuretics in Acute Decompensated Heart Failure
A Phase 2 study testing empagliflozin, Acetazolamide and metolazone in people with Acute Decompensated Heart Failure, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy and safety of empagliflozin, acetazolamide, and metolazone as add-on therapies to loop diuretics in patients with acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- empagliflozin, Acetazolamide and metolazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female patients older than 18 years.
- Hospital admission with clinical diagnosis of acute decompensated heart failure 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).
Who cannot join
- Type 1 diabetes.
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m² or end-stage kidney failure with the need for chronic dialysis treatment.
- A systolic blood pressure of less than 90 mmHg.
- Cardiogenic shock.
- Receipt of acetazolamide maintenance therapy.
- Receipt of an SGLT2 inhibitor, thiazide, or thiazide-like diuretic in the 48 hrs before randomization.
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- Any cause of heart failure leading to decompensation that will need urgent management (eg, acute coronary syndrome, unstable arrhythmias, acute pulmonary embolism).
- Pregnant or breastfeeding women.
- Moderate to severe anemia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university
Tanta
Dalia A Gomaa, MSc in clinical pharmacy, 02+01063410525, dalia_gomaa@pharm.tanta.edu.eg
About this study
Official title: Clinical Study Comparing Empagliflozin, Acetazolamide, and Metolazone as Add-on Therapies to Loop Diuretics in Acute Decompensated Heart Failure
The aim of this study is to compare the efficacy and safety of empagliflozin, acetazolamide, and metolazone as add-on therapies to loop diuretics in patients with acute decompensated heart failure.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- empagliflozin, Acetazolamide, metolazone
- Keywords
- Empagliflozin, Acetazolamide, Metolazone, Acute heart failure, Add-on therapies to Loop diuretics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozinDrug
Empagliflozin may augment the natriuretic and aquaretic actions of loop diuretics in patients with acute decompensated heart failure and it does not typically cause electrolyte disturbances and has been shown to improve outcomes in patients with heart failure
AcetazolamideDrug
Acetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure
metolazoneDrug
Metolazone can augment the action of loop diuretics in patients with acute decompensated heart failure
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin group | Active comparator | will include 22 patients who will receive 10 mg oral empagliflozin administered simultaneously with the first dose of loop diuretics each day for 3 days Receives: Drug: empagliflozin |
| Acetazolamide group | Active comparator | will include 22 patients who will receive 500 mg oral acetazolamide administered simultaneously with the first dose of loop diuretics each day for 3 days Receives: Drug: Acetazolamide |
| Metolazone group | Active comparator | will include 22 patients who will receive 5 mg oral metolazone administered simultaneously with the first dose of loop diuretics each day for 3 days Receives: Drug: metolazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative urine output measured over 3 days
Measured: 3 days
Secondary outcomes (6)
- The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP)
Blood samples will be collected at baseline and after 4 days
Measured: 4 days
The change in serum level of Soluble suppression of tumorigenicity 2 (sST2)
Blood samples will be collected at baseline and after 4 days
Measured: 4 days
The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 )
Urine samples will be collected at baseline and after 3 days
Measured: 3 days
The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7)
Urine samples will be collected at baseline and after 3 days
Measured: 3 days
30-day mortality
Proportion of patients who die within 30 days of randomization
Measured: up to 30 days
Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy
the treating physician will calculate the congestion score, on a scale from 0 to 10 on the basis of the sum of scores for the degree of edema (0 to 4), pleural effusion (0 to 3), and ascites (0 to 3), with higher scores indicating a worse condition on all scales
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Abdelhamid Gomaa, Tanta University
- Investigators
- Dalia A Gomaa, MSc in clinical pharmacy, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372040
- Sponsor's protocol ID
- Acute Heart Failure 2026
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Comparing Empagliflozin, Acetazolamide, and Metolazone as Add-on Therapies to Loop Diuretics in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07372040
- Acronym / sponsor ID
- Acute Heart Failure 2026
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Empagliflozin, Acetazolamide, Metolazone, Acute heart failure, Add-on therapies to Loop diuretics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
The aim of this study is to compare the efficacy and safety of empagliflozin, acetazolamide, and metolazone as add-on therapies to loop diuretics in patients with acute decompensated heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin group | Active comparator | Drug: empagliflozinwill include 22 patients who will receive 10 mg oral empagliflozin administered simultaneously with the first dose of loop diuretics each day for 3 days |
| Acetazolamide group | Active comparator | Drug: Acetazolamidewill include 22 patients who will receive 500 mg oral acetazolamide administered simultaneously with the first dose of loop diuretics each day for 3 days |
| Metolazone group | Active comparator | Drug: metolazonewill include 22 patients who will receive 5 mg oral metolazone administered simultaneously with the first dose of loop diuretics each day 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 (2 listed)
- Male or female patients older than 18 years.
- Hospital admission with clinical diagnosis of acute decompensated heart failure 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).
Key exclusion criteria (9 listed)
- Type 1 diabetes.
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m² or end-stage kidney failure with the need for chronic dialysis treatment.
- A systolic blood pressure of less than 90 mmHg.
- Cardiogenic shock.
- Receipt of acetazolamide maintenance therapy.
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 |
|---|---|---|
| empagliflozinEmpagliflozin may augment the natriuretic and aquaretic actions of loop diuretics in patients with acute decompensated heart failure and it does not typically cause electrolyte disturbances and has been shown to improve outcomes in patients with heart failure | Drug | Empagliflozin group |
| AcetazolamideAcetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure | Drug | Acetazolamide group |
| metolazoneMetolazone can augment the action of loop diuretics in patients with acute decompensated heart failure | Drug | Metolazone group |
Primary outcome
The cumulative urine output measured over 3 days
Time frame: 3 days
6 secondary outcomes
- The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 4 days
The change in serum level of Soluble suppression of tumorigenicity 2 (sST2)
Time frame: 4 days
The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 )
Time frame: 3 days
The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7)
Time frame: 3 days
30-day mortality
Time frame: up to 30 days
Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Dalia A Gomaa, MSc in clinical pharmacy principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing empagliflozin, Acetazolamide and metolazone in people with Acute Decompensated Heart Failure, run by Tanta 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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Feb 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia A Gomaa, MSc in clinical pharmacy (+20+01063410525, dalia_gomaa@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative urine output measured over 3 days (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.