Acute Heart Failure
Conditions
Brief summary
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.
Interventions
DRUGDapagliflozin 10mg
Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Randomized within 24 hours of hospitalization for AHF. 3. Planned use of IV loop diuretic therapy during current hospitalization 4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation.
Exclusion criteria
1. Unable to follow instructions. 2. Treated with any proximal tubular diuretics. 3. Systolic blood pressure of less than 90 mm Hg. 4. An estimated glomerular filtration rate (GFR) of less than 20 ml per 1.73 m2 of body-surface area. 5. Type 1 diabetes mellitus. 6. Dyspnea is primarily due to non-cardiac causes. 7. Cardiogenic shock. 8. Acute coronary syndrome within 30 days prior to randomization. 9. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization. 10. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L). 11. Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dyspnea VAS (Visual analogue scale) | From baseline to day 3 | 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. |
Countries
Egypt
Contacts
Primary ContactHossameldin Sharaf, BSc
Outcome results
None listed