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

NCT ID: NCT06783166

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-08-01

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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dapagliflozin 10mg

Patients will receive once daily dapagliflozin 10 mg orally in addition to loop diuretic therapy and standard care for 3 days.

Group Type: EXPERIMENTAL

Dapagliflozin 10mg

Intervention Type: DRUG

Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.

Acetazolamide 500mg

Patients will receive once daily acetazolamide 500 mg orally in addition to loop diuretic therapy and standard care for 3 days.

Group Type: ACTIVE_COMPARATOR

Acetazolamide 500mg

Intervention Type: DRUG

Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor.

Interventions

Dapagliflozin 10mg

Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.

Intervention Type: DRUG

Acetazolamide 500mg

Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Noha Mansour

Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha Mansour, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura

Moheb Magdy Mouris, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Faculty of Medicine, University of Mansoura

Mohamed El- Husseiny Shams, Professor

Role: STUDY_CHAIR

Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura

Locations

Noha Mansour

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hossameldin Sharaf, BSc

Role: CONTACT

hossamsharaaf@gmail.com

+201009648197

Facility Contacts

Noha Mansour, MD

Role: primary

nohamansaur@mans.edu.eg

+201009648197

Other Identifiers

MS.24.04.2757

Identifier Type: -

Identifier Source: org_study_id