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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozine 10mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg Tab | Drug | patients will receive once daily dapagliflozin 10 mg orally in addition to standard care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noha Mansour, PhD | Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura | Principal Investigator |
| Moheb Magdy Mouris, MD | Department of Cardiology, Faculty of Medicine, University of Mansoura | Principal Investigator |
| Mohamed El-Husseiny Shams, Proffesor | Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noha Mansour | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37923161 | Derived | 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. |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo | Other | patients will receive placebo and standard care. |
|
| All-cause death |
Difference in all cause mortality rate |
| 30 days from discharge |
| All-cause death | Difference in all cause mortality rate | 60 days from discharge |
| Hospital readmission | Difference between groups in rate of readmission after discharge for heart failure related reason | 30 days from discharge |
| Hospital readmission | Difference between groups in rate of readmission after discharge for heart failure reason | 60 days from discharge |
| Urinary sodium 2 hours post randomization | Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups | 2 Hours |
| Difference in serum levels of congestion biomarkers | Difference in serum levels of Nt-ProBNP 4 days post-randomization | 4 days post-randomization |