Clinical trial NCT06783166: Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure
Official title: Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Heart Failure
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in dyspnea VAS (Visual analogue scale)
timeFrame: From baseline to day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Noha Mansour
Study officials:
affiliation: Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
name: Noha Mansour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Faculty of Medicine, University of Mansoura
name: Moheb Magdy Mouris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
name: Mohamed El- Husseiny Shams, Professor
role: STUDY_CHAIR
References: