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This study investigates the comparative clinical outcomes of dapagliflozin, an SGLT-2 inhibitor, versus acetazolamide, a carbonic anhydrase inhibitor, in patients hospitalized with acute heart failure (AHF). The trial aims to assess the effectiveness of these drugs in improving natriuretic and diuretic responses and shortening hospital stays. Dapagliflozin and acetazolamide will be added to standard loop diuretic therapy, and their safety profiles will be evaluated to identify potential side effects. This research seeks to provide evidence for incorporating these drugs into AHF management, with the potential to improve clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin 10mg | Experimental | Patients will receive once daily dapagliflozin 10 mg orally in addition to loop diuretic therapy and standard care for 3 days. |
|
| Acetazolamide 500mg | Active Comparator | Patients will receive once daily acetazolamide 500 mg orally in addition to loop diuretic therapy and standard care for 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg | Drug | Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in dyspnea VAS (Visual analogue scale) | 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 3, and y-axis shows VAS score. Using this approach, AUC for each study day will be calculated, and added together, resulting in an overall VAS AUC score (mm × h) that can be compared across treatment groups. | From baseline to day 3 |
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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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hossameldin Sharaf, BSc | Contact | +201009648197 | hossamsharaaf@gmail.com |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noha Mansour | Recruiting | Al Mansurah | 35516 | Egypt |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Acetazolamide 500mg | Drug | Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor. |
|
| Mohamed El- Husseiny Shams, Professor | Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura | Study Chair |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |