Acute Decompensated Heart FailurePhase 3NCT06535529
Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
A Phase 3 study testing Acetazolamide and Dapagliflozin 10mg in people with Acute Decompensated Heart Failure, run by Helwan University at 1 site in Egypt.
Trial summary
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. 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?
- Acetazolamide and Dapagliflozin 10mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2024to 1 Sep 2025
- Phase
- Phase 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
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Critical Care Medicine Department - Cairo University Hospitals.
Cairo
Nouran M Anwar, 01124119559, .Nouran.Anwar@pharm.helwan.edu.eg
About this study
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.
Read more
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
Read the detailed description
- Study design
- Prospective, open-label, randomized, two-armed parallel comparator study.
- Participants recruited in the study must provide written informed consent after obtaining ethical approval from ethics committee.
- Study settings Critical Care Medicine Department - Cairo University Hospitals. C. Population of study Adult patients who are admitted to Critical Care Medicine Department - Cairo University Hospitals because of acute decompensated heart failure will be screened for inclusion into the study. Patients who have at least one clinical sign of volume overload (i.e., edema, pleural effusion, or ascites) and ECHO-confirmed HF at screening will be included in the study.
D.Treatment :
I.V loop diuretics
At the moment of randomization, oral loop diuretics are stopped. Patients need to empty their bladder before administration of the first dose of loop diuretics and all will receive an intravenous loop diuretic at double the oral maintenance dose, administered as a single bolus immediately after randomization and split into more than two doses (separated by ≥6 hours) on each of the next 2 days.
Group 1: Oral Acetazolamide Together with the initial bolus dose of loop diuretics, patients will receive 500 mg oral Acetazolamide. Time of subsequent dose of acetazolamide taken once daily will start together with the first maintenance loop diuretic dose.
Group 2: Oral Dapagliflozin Together with the initial dose of loop diuretics, patients will receive 10 mg Dapagliflozin.
Time of subsequent dose of Dapagliflozin taken once daily will start together with the first maintenance loop diuretic dose.
- Study tools
Modified ADVOR Score The modified ADVOR congestion score will be calculated on a scale from 0 to 10 based on 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. This score will be calculated for each included patient before the administration of the first dose of diuretics during the treatment phase, at the end of the study.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Acetazolamide, Dapagliflozin 10mg
- Keywords
- Acute Heart failure, ADHF, Acetazolamide, SGLT2 inhibitors, SGLT2i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Cidamix
Patients will receive acetazolamide 500 mg once daily for 3 days as add on therapy to IV loop diuretics
Dapagliflozin 10mgDrug
Also called Forxiga
patient will receive oral dapagliflozin 10 mg once daily for 3 days as add on therapy to IV loop diuretics
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide + Standard Care | Active comparator | Participants in this arm will receive:
1. Acetazolamide: 500 mg orally, once daily for 3 days
2. Intravenous loop diuretics: Administered at double the oral maintenance dose, given as follows:
* Initial dose: Single bolus immediately after randomization
* Subsequent doses: Split into two or more doses (separated by ≥6 hours) on each of the next 2 days The specific loop diuretic used (e.g., furosemide) will be determined by the treating physician based on the patient's prior medication regimen and clinical status. Receives: Drug: Acetazolamide |
| Dapagliflozin + Standard Care | Active comparator | Participants in this arm will receive:
1. Dapagliflozin: 10 mg orally, once daily for 3 days
2. Intravenous loop diuretics: Administered as described in Arm 1 Receives: Drug: Dapagliflozin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Absolute change in NT-proBNP levels from baseline to end of study period
Measured: From baseline to day 5 or intensive care unit (ICU) discharge, whichever occurs first
calculating of weight loss Loop diuretic efficiency
Weight loss (in kg) per 40 mg of intravenous furosemide or equivalent dose of other loop diuretics
Measured: 72 hours from initiation of treatment
Secondary outcomes (6)
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)
Measured: 72 hours from initiation of treatment
Duration of the index hospital admission
Number of days from randomization until the date of discharge
Measured: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 weeks
30-day mortality
Proportion of patients who die from any cause within 30 days of randomization
Measured: Up to 30 days
Cumulative dose of intravenous loop diuretics
Total milligrams of intravenous furosemide or equivalent dose of other loop diuretics administered
Measured: 5 days
Incidence of treatment-related metabolic acidosis
Proportion of patients developing metabolic acidosis requiring sodium bicarbonate (NaHCO3) supplementation
Measured: 5 days
percent of worsening renal failure (WRF)
Proportion of patients experiencing either: a) An increase in serum creatinine > 0.3 mg/dL from baseline, or b) A decrease in estimated glomerular filtration rate (eGFR) > 20% from baseline
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start24 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open-label, randomized, two-armed parallel comparator study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud I Mostafa, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535529
- Sponsor's protocol ID
- Acetazolamide vs Dapa in ADHF
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mullens W, Verbrugge FH, Nijst P, Martens P, Tartaglia K, Theunissen E, Bruckers L, Droogne W, Troisfontaines P, Damman K, Lassus J, Mebazaa A, Filippatos G, Ruschitzka F, Dupont M. Rationale and design of the ADVOR (Acetazolamide in Decompensated Heart Failure with Volume Overload) trial. Eur J Heart Fail. 2018 Nov;20(11):1591-1600. doi: 10.1002/ejhf.1307. Epub 2018 Sep 21.
PubMed 30238574Mullens W, Dauw J, Martens P, Verbrugge FH, Nijst P, Meekers E, Tartaglia K, Chenot F, Moubayed S, Dierckx R, Blouard P, Troisfontaines P, Derthoo D, Smolders W, Bruckers L, Droogne W, Ter Maaten JM, Damman K, Lassus J, Mebazaa A, Filippatos G, Ruschitzka F, Dupont M; ADVOR Study Group. Acetazolamide in Acute Decompensated Heart Failure with Volume Overload. N Engl J Med. 2022 Sep 29;387(13):1185-1195. doi: 10.1056/NEJMoa2203094. Epub 2022 Aug 27.
PubMed 36027559Mullens W, Schulze PC, Westphal J, Bogoviku J, Bauersachs J. Great debate: in patients with decompensated heart failure, acetazolamide in addition to loop diuretics is the first choice. Eur Heart J. 2023 Jun 25;44(24):2159-2169. doi: 10.1093/eurheartj/ehad266.
PubMed 37207453Malik BA, Nnodebe I, Fayaz A, Inayat H, Murtaza SF, Umer M, Zaidi SAT, Amin A. Effect of Acetazolamide as Add-On Diuretic Therapy in Patients With Heart Failure: A Meta-Analysis. Cureus. 2023 Apr 18;15(4):e37792. doi: 10.7759/cureus.37792. eCollection 2023 Apr.
PubMed 37213994Sabina M, Barakat Z, Feliciano A, Lamb A, Alsamman MM. Unlocking the Potential of Acetazolamide: A Literature Review of an Adjunctive Approach in Heart Failure Management. J Clin Med. 2024 Jan 4;13(1):288. doi: 10.3390/jcm13010288.
PubMed 38202295Kosiorek A, Urban S, Detyna J, Biegus J, Hurkacz M, Zymlinski R. Diuretic, natriuretic, and chloride-regaining effects of oral acetazolamide as an add-on therapy for acute heart failure with volume overload: a single-center, prospective, randomized study. Pol Arch Intern Med. 2023 Dec 21;133(12):16526. doi: 10.20452/pamw.16526. Epub 2023 Jul 6.
PubMed 37415505Siddiqi AK, Maniya MT, Alam MT, Ambrosy AP, Fudim M, Greene SJ, Khan MS. Acetazolamide as an Adjunctive Diuretic Therapy for Patients with Acute Decompensated Heart Failure: A Systematic Review and Meta-Analysis. Am J Cardiovasc Drugs. 2024 Mar;24(2):273-284. doi: 10.1007/s40256-024-00633-9. Epub 2024 Feb 28.
PubMed 38416359Cox ZL, Collins SP, Hernandez GA, McRae AT 3rd, Davidson BT, Adams K, Aaron M, Cunningham L, Jenkins CA, Lindsell CJ, Harrell FE Jr, Kampe C, Miller KF, Stubblefield WB, Lindenfeld J. Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure. J Am Coll Cardiol. 2024 Apr 9;83(14):1295-1306. doi: 10.1016/j.jacc.2024.02.009.
PubMed 38569758
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06535529
- Acronym / sponsor ID
- Acetazolamide vs Dapa in ADHF
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Acute Heart failure, ADHF, Acetazolamide, SGLT2 inhibitors, SGLT2i
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 24 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 Aug 2024 (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 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
Detailed description
- Study design
- Prospective, open-label, randomized, two-armed parallel comparator study.
- Participants recruited in the study must provide written informed consent after obtaining ethical approval from ethics committee.
- Study settings Critical Care Medicine Department - Cairo University Hospitals. C. Population of study Adult patients who are admitted to Critical Care Medicine Department - Cairo University Hospitals because of acute decompensated heart failure will be screened for inclusion into the study. Patients who have at least one clinical sign of volume overload (i.e., edema, pleural effusion, or ascites) and ECHO-confirmed HF at screening will be included in the study.
D.Treatment :
I.V loop diuretics
At the moment of randomization, oral loop diuretics are stopped. Patients need to empty their bladder before administration of the first dose of loop diuretics and all will receive an intravenous loop diuretic at double the oral maintenance dose, administered as a single bolus immediately after randomization and split into more than two doses (separated by ≥6 hours) on each of the next 2 days.
Group 1: Oral Acetazolamide Together with the initial bolus dose of loop diuretics, patients will receive 500 mg oral Acetazolamide. Time of subsequent dose of acetazolamide taken once daily will start together with the first maintenance loop diuretic dose.
Group 2: Oral Dapagliflozin Together with the initial dose of loop diuretics, patients will receive 10 mg Dapagliflozin.
Time of subsequent dose of Dapagliflozin taken once daily will start together with the first maintenance loop diuretic dose.
- Study tools
Modified ADVOR Score The modified ADVOR congestion score will be calculated on a scale from 0 to 10 based on 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. This score will be calculated for each included patient before the administration of the first dose of diuretics during the treatment phase, at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label, randomized, two-armed parallel comparator study.
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide + Standard Care | Active comparator | Drug: AcetazolamideParticipants in this arm will receive: 1. Acetazolamide: 500 mg orally, once daily for 3 days 2. Intravenous loop diuretics: Administered at double the oral maintenance dose, given as follows: * Initial dose: Single bolus immediately after randomization * Subsequent doses: Split into two or more doses (separated by ≥6 hours) on each of the next 2 days The specific loop diuretic used (e.g., furosemide) will be determined by the treating physician based on the patient's prior medication regimen and clinical status. |
| Dapagliflozin + Standard Care | Active comparator | Drug: Dapagliflozin 10mgParticipants in this arm will receive: 1. Dapagliflozin: 10 mg orally, once daily for 3 days 2. Intravenous loop diuretics: Administered as described in Arm 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| AcetazolamideAlso: CidamixPatients will receive acetazolamide 500 mg once daily for 3 days as add on therapy to IV loop diuretics | Drug | Acetazolamide + Standard Care |
| Dapagliflozin 10mgAlso: Forxigapatient will receive oral dapagliflozin 10 mg once daily for 3 days as add on therapy to IV loop diuretics | Drug | Dapagliflozin + Standard Care |
Primary outcome
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: From baseline to day 5 or intensive care unit (ICU) discharge, whichever occurs first
Absolute change in NT-proBNP levels from baseline to end of study period
calculating of weight loss Loop diuretic efficiency
Time frame: 72 hours from initiation of treatment
Weight loss (in kg) per 40 mg of intravenous furosemide or equivalent dose of other loop diuretics
6 secondary outcomes
Number of Participants with Successful decongestion
Time frame: 72 hours from initiation of treatment
Duration of the index hospital admission
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
30-day mortality
Time frame: Up to 30 days
Cumulative dose of intravenous loop diuretics
Time frame: 5 days
Incidence of treatment-related metabolic acidosis
Time frame: 5 days
percent of worsening renal failure (WRF)
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 30238574Mullens W, Verbrugge FH, Nijst P, Martens P, Tartaglia K, Theunissen E, Bruckers L, Droogne W, Troisfontaines P, Damman K, Lassus J, Mebazaa A, Filippatos G, Ruschitzka F, Dupont M. Rationale and design of the ADVOR (Acetazolamide in Decompensated Heart Failure with Volume Overload) trial. Eur J Heart Fail. 2018 Nov;20(11):1591-1600. doi: 10.1002/ejhf.1307. Epub 2018 Sep 21.
- Background: PubMed 36027559Mullens W, Dauw J, Martens P, Verbrugge FH, Nijst P, Meekers E, Tartaglia K, Chenot F, Moubayed S, Dierckx R, Blouard P, Troisfontaines P, Derthoo D, Smolders W, Bruckers L, Droogne W, Ter Maaten JM, Damman K, Lassus J, Mebazaa A, Filippatos G, Ruschitzka F, Dupont M; ADVOR Study Group. Acetazolamide in Acute Decompensated Heart Failure with Volume Overload. N Engl J Med. 2022 Sep 29;387(13):1185-1195. doi: 10.1056/NEJMoa2203094. Epub 2022 Aug 27.
- Background: PubMed 37207453Mullens W, Schulze PC, Westphal J, Bogoviku J, Bauersachs J. Great debate: in patients with decompensated heart failure, acetazolamide in addition to loop diuretics is the first choice. Eur Heart J. 2023 Jun 25;44(24):2159-2169. doi: 10.1093/eurheartj/ehad266.
- Background: PubMed 37213994Malik BA, Nnodebe I, Fayaz A, Inayat H, Murtaza SF, Umer M, Zaidi SAT, Amin A. Effect of Acetazolamide as Add-On Diuretic Therapy in Patients With Heart Failure: A Meta-Analysis. Cureus. 2023 Apr 18;15(4):e37792. doi: 10.7759/cureus.37792. eCollection 2023 Apr.
- Background: PubMed 38202295Sabina M, Barakat Z, Feliciano A, Lamb A, Alsamman MM. Unlocking the Potential of Acetazolamide: A Literature Review of an Adjunctive Approach in Heart Failure Management. J Clin Med. 2024 Jan 4;13(1):288. doi: 10.3390/jcm13010288.
- Background: PubMed 37415505Kosiorek A, Urban S, Detyna J, Biegus J, Hurkacz M, Zymlinski R. Diuretic, natriuretic, and chloride-regaining effects of oral acetazolamide as an add-on therapy for acute heart failure with volume overload: a single-center, prospective, randomized study. Pol Arch Intern Med. 2023 Dec 21;133(12):16526. doi: 10.20452/pamw.16526. Epub 2023 Jul 6.
- Background: PubMed 38416359Siddiqi AK, Maniya MT, Alam MT, Ambrosy AP, Fudim M, Greene SJ, Khan MS. Acetazolamide as an Adjunctive Diuretic Therapy for Patients with Acute Decompensated Heart Failure: A Systematic Review and Meta-Analysis. Am J Cardiovasc Drugs. 2024 Mar;24(2):273-284. doi: 10.1007/s40256-024-00633-9. Epub 2024 Feb 28.
- Background: PubMed 38569758Cox ZL, Collins SP, Hernandez GA, McRae AT 3rd, Davidson BT, Adams K, Aaron M, Cunningham L, Jenkins CA, Lindsell CJ, Harrell FE Jr, Kampe C, Miller KF, Stubblefield WB, Lindenfeld J. Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure. J Am Coll Cardiol. 2024 Apr 9;83(14):1295-1306. doi: 10.1016/j.jacc.2024.02.009.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetazolamide and Dapagliflozin 10mg in people with Acute Decompensated Heart Failure, run by Helwan 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nouran Mo Anwar, Bachelor (01124119559, Nouran.Anwar@pharm.helwan.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-terminal pro-B-type natriuretic peptide (NT-proBNP) (time frame: From baseline to day 5 or intensive care unit (ICU) discharge, whichever occurs first). The study lists 2 primary outcomes in all. 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 NCT06535529, which also lists 8 linked publications.
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 5 Aug 2024.