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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Heart Failure
• Intervention / Treatment: Drug: Dapagliflozin 10mg; Drug: Acetazolamide 500mg

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hossameldin Sharaf, BSc; Phone Number: +201009648197; Email: hossamsharaaf@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Recruiting
    • Noha Mansour
    • Contact: Noha Mansour, MD; Phone Number: +201009648197; Email: nohamansaur@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin 10mg; Patients will receive once daily dapagliflozin 10 mg orally in addition to loop diuretic therapy and standard care for 3 days.	Drug: Dapagliflozin 10mg; Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Active Comparator: Acetazolamide 500mg; Patients will receive once daily acetazolamide 500 mg orally in addition to loop diuretic therapy and standard care for 3 days.	Drug: Acetazolamide 500mg; Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: 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; Study Chair: Mohamed El- Husseiny Shams, Professor, Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Enzyme Inhibitors; Diuretics; Natriuretic Agents; Anticonvulsants; Carbonic Anhydrase Inhibitors; Dapagliflozin; Acetazolamide
• Other Study ID Numbers: MS.24.04.2757

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No