Acute Decompensated Heart Failure (ADHF)Phase 4DapagliflozinNCT07076615
The Effect of Dapagliflozin on Patients With Cardiomyopathy
A Phase 4 study testing Dapagliflozin (DAPA) and Diuretic in people with Acute Decompensated Heart Failure (ADHF), run by May Mohamed Abdalla at 1 site in Egypt.
Trial summary
This randomized controlled trial evaluates the efficacy and tolerability of early initiation of dapagliflozin in adult patients hospitalized with acute heart failure (AHF). The study aims to assess the effect of dapagliflozin on pulmonary congestion as measured by lung ultrasound (LUS), length of hospital stay, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- Dapagliflozin (DAPA) and Diuretic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 31 May 2026
- Phase
- Phase 4
- 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
- 18 years or older
- Acute heart failure as defined by the 2022 American College of Cardiology/American Heart Association (Heidenreich et al., 2022) or 2021 European Society of Cardiology (McDonagh et al., 2021) guidelines, based on typical symptoms and signs of heart failure requiring hospitalization or emergency department visit
- Elevated natriuretic peptide levels
- Includes heart failure with reduced, mildly reduced, or preserved ejection fraction
- Planned use of intravenous diuretic therapy
Who cannot join
- Type 1 diabetes mellitus
- Urinary tract or genital infection
- Hypovolemia
- Diabetic ketoacidosis
- Serum glucose < 80 mg/dL at enrollment
- Systolic blood pressure < 90 mmHg at enrollment
Show all 11Show fewer
- History of hypersensitivity to any SGLT2 inhibitor
- Pregnant or breastfeeding women
- Severe primary valvular lesion requiring intervention
- Severe hepatic impairment (Child-Pugh class C)
- Estimated glomerular filtration rate < 25 mL/min/1.73 m² (by MDRD equation)
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial evaluates the efficacy and tolerability of early initiation of dapagliflozin in adult patients hospitalized with acute heart failure (AHF). The study aims to assess the effect of dapagliflozin on pulmonary congestion as measured by lung ultrasound (LUS), length of hospital stay, and cardiac and renal biomarkers. A total of 100 patients will be randomized into two groups: one receiving dapagliflozin plus diuretics and the other receiving diuretics alone. Key outcomes include the reduction of extravascular lung water (assessed by B-lines in LUS), improved diuretic response, changes in NT-proBNP, sST2, CA-125, and NGAL levels, and incidence of acute kidney injury. The study will be conducted at the Cardiology and ICU departments at Kasr Al Ainy Hospital, Cairo University
Read the detailed description
Acute Heart Failure (AHF) is a life-threatening syndrome and a leading cause of hospitalization worldwide. Effective decongestion during AHF episodes is essential for improving patient outcomes and reducing hospital readmissions. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, particularly dapagliflozin, have shown significant promise in improving cardiovascular outcomes in chronic heart failure; however, their role during acute episodes remains under active investigation.
This prospective, randomized controlled trial aims to assess the efficacy and safety of early dapagliflozin initiation in hospitalized adult patients with AHF, irrespective of diabetes status. A total of 100 patients admitted to the Cardiology and Intensive Care Departments of Kasr Al Ainy Hospital, Cairo University, will be enrolled and randomized (1:1) to either standard diuretic therapy alone or dapagliflozin (10 mg once daily) plus diuretics.
The study's primary endpoint is the degree of pulmonary congestion, evaluated through lung ultrasound (LUS) using an 8-zone scanning protocol and quantification of B-lines. Secondary outcomes include hospital length of stay, diuretic response, changes in cardiac biomarkers (NT-proBNP, sST2, and CA-125), renal biomarker NGAL, and incidence of acute kidney injury.
LUS and echocardiography will be performed by certified intensivists using standardized protocols. Biomarkers will be measured via ELISA kits at three time points: within 24 hours of admission, and at discharge.
The hypothesis is that early use of dapagliflozin in AHF enhances decongestion, improves natriuretic response, and enables earlier hospital discharge without increasing adverse renal or metabolic events.
The results of this study will provide valuable insights into the use of SGLT2 inhibitors during the acute phase of heart failure and may inform future clinical practice guidelines.
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Being tested
- Dapagliflozin (DAPA), Diuretic
- Keywords
- ADHF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (DAPA)Drug
Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy
DiureticDrug
Arm B (Control Group): Receives standard intravenous diuretic therapy alone
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin + Diuretic (Intervention Group) | Experimental | Participants will receive dapagliflozin 10 mg orally once daily in addition to standard intravenous diuretic therapy.
Intervention(s):
Drug: Dapagliflozin (DAPA)
Dose: 10 mg once daily
Route: Oral
Other Name(s): Forxiga
Drug: Intravenous Diuretic
Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol Receives: Drug: Dapagliflozin (DAPA); Drug: Diuretic |
| Active Comparator | Active comparator | Participants will receive standard intravenous diuretic therapy alone, without dapagliflozin.
Intervention(s):
Drug: Intravenous Diuretic
Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol Receives: Drug: Diuretic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS)
To evaluate the effect of dapagliflozin on pulmonary congestion in patients hospitalized with acute heart failure, using lung ultrasound to measure the number of B-lines at defined intervals during hospitalization.
Measured: Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)
Secondary outcomes (7)
Effect of Dapagliflozin on Hospital Length of Stay
To assess the effect of dapagliflozin on the duration of hospitalization, measured in total days from admission to discharge.
Measured: From hospital admission to hospital discharge (an average of 7 days)
Effect of Dapagliflozin on Renal Biomarker NGAL
To assess the effect of dapagliflozin on renal injury using the neutrophil gelatinase-associated lipocalin (NGAL) level in ng/mL as a renal biomarker.
Measured: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
Change in NT-proBNP Levels
To assess the change in NT-proBNP levels (pg/mL) in patients receiving dapagliflozin during hospitalization for acute heart failure.
Measured: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
Change in Net Fluid Balance
To determine the net fluid balance (fluid input minus output) (mL per 24 hours) to evaluate diuretic efficiency in patients receiving dapagliflozin.
Measured: Day 1, Day 2, and Day 3 of hospitalization
Incidence of Acute Kidney Injury (AKI) Based on KDIGO Criteria
To determine the incidence of acute kidney injury (AKI) according to KDIGO guidelines in patients receiving dapagliflozin during hospitalization.
Measured: From admission (Day 1) through hospital discharge (up to 14 days)
Change in sST2 Levels
To evaluate the effect of dapagliflozin on soluble ST2 (sST2) (ng/mL) concentrations in patients with acute heart failure.
Measured: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
Change in CA-125 Levels
To measure the change in CA-125 (Cancer Antigen 125) levels (U/mL) in patients treated with dapagliflozin during hospitalization for acute heart failure.
Measured: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two groups in parallel for the duration of the study. Arm A: Receives dapagliflozin (10 mg daily) + standard diuretic therapy Arm B: Receives standard diuretic therapy alone Each group is treated simultaneously, and outcomes are compared between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- May Mohamed Abdalla
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, May Mohamed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076615
- Sponsor's protocol ID
- N-73-2024
- Other IDs
- PO.3.4.1
- Acronym
- Dapagliflozin
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, it is undecided whether de-identified individual participant data (IPD), including clinical and laboratory data collected during the study, will be shared with external researchers. A final decision regarding IPD sharing will be made upon study completion, taking into consideration ethical, legal, and regulatory factors.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dapagliflozin on Patients With Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07076615
- Acronym / sponsor ID
- Dapagliflozin / N-73-2024
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Keywords
- ADHF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- May Mohamed AbdallaUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 22 Jul 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 randomized controlled trial evaluates the efficacy and tolerability of early initiation of dapagliflozin in adult patients hospitalized with acute heart failure (AHF). The study aims to assess the effect of dapagliflozin on pulmonary congestion as measured by lung ultrasound (LUS), length of hospital stay, and cardiac and renal biomarkers. A total of 100 patients will be randomized into two groups: one receiving dapagliflozin plus diuretics and the other receiving diuretics alone. Key outcomes include the reduction of extravascular lung water (assessed by B-lines in LUS), improved diuretic response, changes in NT-proBNP, sST2, CA-125, and NGAL levels, and incidence of acute kidney injury. The study will be conducted at the Cardiology and ICU departments at Kasr Al Ainy Hospital, Cairo University
Detailed description
Acute Heart Failure (AHF) is a life-threatening syndrome and a leading cause of hospitalization worldwide. Effective decongestion during AHF episodes is essential for improving patient outcomes and reducing hospital readmissions. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, particularly dapagliflozin, have shown significant promise in improving cardiovascular outcomes in chronic heart failure; however, their role during acute episodes remains under active investigation.
This prospective, randomized controlled trial aims to assess the efficacy and safety of early dapagliflozin initiation in hospitalized adult patients with AHF, irrespective of diabetes status. A total of 100 patients admitted to the Cardiology and Intensive Care Departments of Kasr Al Ainy Hospital, Cairo University, will be enrolled and randomized (1:1) to either standard diuretic therapy alone or dapagliflozin (10 mg once daily) plus diuretics.
The study's primary endpoint is the degree of pulmonary congestion, evaluated through lung ultrasound (LUS) using an 8-zone scanning protocol and quantification of B-lines. Secondary outcomes include hospital length of stay, diuretic response, changes in cardiac biomarkers (NT-proBNP, sST2, and CA-125), renal biomarker NGAL, and incidence of acute kidney injury.
LUS and echocardiography will be performed by certified intensivists using standardized protocols. Biomarkers will be measured via ELISA kits at three time points: within 24 hours of admission, and at discharge.
The hypothesis is that early use of dapagliflozin in AHF enhances decongestion, improves natriuretic response, and enables earlier hospital discharge without increasing adverse renal or metabolic events.
The results of this study will provide valuable insights into the use of SGLT2 inhibitors during the acute phase of heart failure and may inform future clinical practice guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two groups in parallel for the duration of the study. Arm A: Receives dapagliflozin (10 mg daily) + standard diuretic therapy Arm B: Receives standard diuretic therapy alone Each group is treated simultaneously, and outcomes are compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin + Diuretic (Intervention Group) | Experimental | Drug: Dapagliflozin (DAPA), Drug: DiureticParticipants will receive dapagliflozin 10 mg orally once daily in addition to standard intravenous diuretic therapy. Intervention(s): Drug: Dapagliflozin (DAPA) Dose: 10 mg once daily Route: Oral Other Name(s): Forxiga Drug: Intravenous Diuretic Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol |
| Active Comparator | Active comparator | Drug: DiureticParticipants will receive standard intravenous diuretic therapy alone, without dapagliflozin. Intervention(s): Drug: Intravenous Diuretic Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Acute heart failure as defined by the 2022 American College of Cardiology/American Heart Association (Heidenreich et al., 2022) or 2021 European Society of Cardiology (McDonagh et al., 2021) guidelines, based on typical symptoms and signs of heart failure requiring hospitalization or emergency department visit
- Elevated natriuretic peptide levels
- Includes heart failure with reduced, mildly reduced, or preserved ejection fraction
- Planned use of intravenous diuretic therapy
Key exclusion criteria (11 listed)
- Type 1 diabetes mellitus
- Urinary tract or genital infection
- Hypovolemia
- Diabetic ketoacidosis
- Serum glucose < 80 mg/dL at enrollment
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 (DAPA)Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy | Drug | Dapagliflozin + Diuretic (Intervention Group) |
| DiureticArm B (Control Group): Receives standard intravenous diuretic therapy alone | Drug | Active Comparator, Dapagliflozin + Diuretic (Intervention Group) |
Primary outcome
Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS)
Time frame: Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)
To evaluate the effect of dapagliflozin on pulmonary congestion in patients hospitalized with acute heart failure, using lung ultrasound to measure the number of B-lines at defined intervals during hospitalization.
7 secondary outcomes
Effect of Dapagliflozin on Hospital Length of Stay
Time frame: From hospital admission to hospital discharge (an average of 7 days)
Effect of Dapagliflozin on Renal Biomarker NGAL
Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
Change in NT-proBNP Levels
Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
Change in Net Fluid Balance
Time frame: Day 1, Day 2, and Day 3 of hospitalization
Incidence of Acute Kidney Injury (AKI) Based on KDIGO Criteria
Time frame: From admission (Day 1) through hospital discharge (up to 14 days)
Change in sST2 Levels
Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
Change in CA-125 Levels
Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)
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 15 Sep 2026.
- Individual participant dataSharing planned: Undecided. At this time, it is undecided whether de-identified individual participant data (IPD), including clinical and laboratory data collected during the study, will be shared with external researchers. A final decision regarding IPD sharing will be made upon study completion, taking into consideration ethical, legal, and regulatory factors.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin (DAPA) and Diuretic in people with Acute Decompensated Heart Failure (ADHF), run by May Mohamed Abdalla 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 5 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 15 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS) (time frame: Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)). 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 15 Sep 2026.