Comparing dapagliflozin and acetazolamide for treating acute heart failure

Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure

This study is testing whether dapagliflozin or acetazolamide works better for helping people in the hospital with acute heart failure feel better and possibly shorten their hospital stay.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mansoura University (Academic / other)
• Locations: 1 site (Al Mansurah)
• Trial ID: NCT06783166 on ClinicalTrials.gov

What this trial studies

This study investigates the clinical outcomes of dapagliflozin, an SGLT-2 inhibitor, compared to acetazolamide, a carbonic anhydrase inhibitor, in patients hospitalized with acute heart failure. The trial aims to evaluate the effectiveness of these medications in enhancing natriuretic and diuretic responses while potentially reducing hospital stays. Both drugs will be administered alongside standard loop diuretic therapy, and their safety profiles will be monitored to identify any side effects. The ultimate goal is to provide evidence for the integration of these treatments into the management of acute heart failure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older hospitalized for hypervolemic acute heart failure with evidence of congestion.

Not a fit: Patients with systolic blood pressure below 90 mm Hg or those unable to follow instructions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved clinical outcomes and shorter hospital stays for patients with acute heart failure.

How similar studies have performed: Other studies have shown promising results with SGLT-2 inhibitors in heart failure management, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Al Mansurah

• Noha Mansour — Al Mansurah, Egypt (Recruiting)

Study contacts

• Principal investigator: Noha Mansour, PhD — Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
• Study coordinator: Hossameldin Sharaf, BSc

Conditions Acute Heart Failure