Acute Heart FailurePhase 2/3NCT05406505
Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)
A Phase 2/3 study testing Dapagliflozin 10mg Tab in people with Acute Heart Failure, run by Mansoura University at 1 site in Egypt.
Trial summary
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. 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 Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2022to 1 Jul 2023
- 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 30 ml/min/1.73m2 by the MDRD equation
- For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission.
Who cannot join
- Type 1 diabetes mellitus.
- Dyspnea primarily due to non-cardiac causes.
- 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).
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- Pregnant or nursing (lactating) women.
- Heart failure due to drug toxicity
- Adherence to medication less than 95%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adjuvant Dapagliflozin on Improving the Treatment of Congestion in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.
- Conditions
- Acute Heart Failure
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Keywords
- Diabetic and non diabetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
patients will receive once daily dapagliflozin 10 mg orally in addition to standard care
PlaceboOther
patients will receive placebo and standard care.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozine 10mg | Experimental | Not described Receives: Drug: Dapagliflozin 10mg Tab |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspnea ( Visual analogue scale) (VAS)
- 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 5, and y-axis shows VAS score. the overall VAS AUC score (mm × h) will be compared across treatment groups
Measured: From baseline to day 4
Secondary outcomes (7)
Incidence of worsening heart failure (HF)
Defined as worsening signs and/or symptoms of HF that require IV inotropic therapy or admission to an intensive care unit or mechanical ventilatory, renal or circulatory support.
Measured: From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days
All-cause death
Difference in all cause mortality rate
Measured: 30 days from discharge
All-cause death
Difference in all cause mortality rate
Measured: 60 days from discharge
Hospital readmission
Difference between groups in rate of readmission after discharge for heart failure related reason
Measured: 30 days from discharge
Hospital readmission
Difference between groups in rate of readmission after discharge for heart failure reason
Measured: 60 days from discharge
Urinary sodium 2 hours post randomization
Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups
Measured: 2 Hours
Difference in serum levels of congestion biomarkers
Difference in serum levels of Nt-ProBNP 4 days post-randomization
Measured: 4 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start25 Apr 2022
- Primary completion1 May 2023
- Study completion1 Jul 2023
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 87 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, Proffesor, Study chair, Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406505
- Sponsor's protocol ID
- 2022-61
- Status last verified
- Aug 2023
- First submitted
- 12 Nov 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Emara AN, Wadie M, Mansour NO, Shams MEE. The clinical outcomes of dapagliflozin in patients with acute heart failure: A randomized controlled trial (DAPA-RESPONSE-AHF). Eur J Pharmacol. 2023 Dec 15;961:176179. doi: 10.1016/j.ejphar.2023.176179. Epub 2023 Nov 2.
PubMed 37923161
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjuvant Dapagliflozin on Improving the Treatment of Congestion in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)
- ClinicalTrials.gov ID
- NCT05406505
- Acronym / sponsor ID
- 2022-61
- Conditions
- Acute Heart Failure
- Keywords
- Diabetic and non diabetic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 6 Jun 2022 (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.
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozine 10mg | Experimental | Drug: Dapagliflozin 10mg Tab |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:
- 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
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus.
- Dyspnea primarily due to non-cardiac causes.
- 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.
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 10mg Tabpatients will receive once daily dapagliflozin 10 mg orally in addition to standard care | Drug | Dapagliflozine 10mg |
| Placebopatients will receive placebo and standard care. | Other | Placebo |
Primary outcome
Change in dyspnea ( Visual analogue scale) (VAS)
Time frame: From baseline to day 4
• 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 5, and y-axis shows VAS score. the overall VAS AUC score (mm × h) will be compared across treatment groups
7 secondary outcomes
Incidence of worsening heart failure (HF)
Time frame: From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days
All-cause death
Time frame: 30 days from discharge
All-cause death
Time frame: 60 days from discharge
Hospital readmission
Time frame: 30 days from discharge
Hospital readmission
Time frame: 60 days from discharge
Urinary sodium 2 hours post randomization
Time frame: 2 Hours
Difference in serum levels of congestion biomarkers
Time frame: 4 days post-randomization
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 4 Aug 2023.
- Derived from this study: PubMed 37923161Emara AN, Wadie M, Mansour NO, Shams MEE. The clinical outcomes of dapagliflozin in patients with acute heart failure: A randomized controlled trial (DAPA-RESPONSE-AHF). Eur J Pharmacol. 2023 Dec 15;961:176179. doi: 10.1016/j.ejphar.2023.176179. Epub 2023 Nov 2.
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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, Proffesor 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 Tab 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 8 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: finished, as of the sponsor's last update on 4 Aug 2023. 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. Some participants in this study may receive a placebo. 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 ( Visual analogue scale) (VAS) (time frame: From baseline to day 4). 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 NCT05406505, 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 4 Aug 2023.