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

NCT06783166 | Recruiting Phase 2

• 1 other identifier: MS.24.04.2757
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dapagliflozin 10mg

EXPERIMENTAL

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

Drug: Dapagliflozin 10mg

Acetazolamide 500mg

ACTIVE COMPARATOR

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

Drug: Acetazolamide 500mg

Interventions

Dapagliflozin 10mg DRUG

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

Dapagliflozin 10mg

Acetazolamide 500mg DRUG

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

Acetazolamide 500mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:
• 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.
• Randomized within 24 hours of hospitalization for AHF.
• Planned use of IV loop diuretic therapy during current hospitalization
• Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation.

You may not qualify if:

• Unable to follow instructions.
• Treated with any proximal tubular diuretics.
• Systolic blood pressure of less than 90 mm Hg.
• An estimated glomerular filtration rate (GFR) of less than 20 ml per 1.73 m2 of body-surface area.
• Type 1 diabetes mellitus.
• Dyspnea is primarily due to non-cardiac causes.
• Cardiogenic shock.
• Acute coronary syndrome within 30 days prior to randomization.
• Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
• Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L).
• Pregnant or nursing (lactating) women.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Noha Mansour

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

dapagliflozin; Acetazolamide

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Mohamed El- Husseiny Shams, Professor

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

  STUDY CHAIR

Central Study Contacts

Hossameldin Sharaf, BSc

CONTACT

+201009648197; hossamsharaaf@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: August 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

EG (1)