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Search / Trial NCT06783166

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

Launched by MANSOURA UNIVERSITY · Jan 14, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how well two different medications, dapagliflozin and acetazolamide, work for patients who are hospitalized with acute heart failure (AHF). Acute heart failure is when the heart suddenly can't pump blood as well as it should, leading to symptoms like swollen legs and difficulty breathing. The trial aims to see if adding dapagliflozin or acetazolamide to standard treatment helps patients feel better, improves their ability to urinate, and shortens their hospital stay. Researchers will also monitor any side effects from these medications to ensure they are safe for use.

To join this study, participants need to be adults aged 18 or older who are currently in the hospital for acute heart failure and have certain signs of fluid buildup, like swelling or difficulty breathing. They should be planned to receive intravenous (IV) loop diuretics, which are medications that help remove excess fluid. Participants will be randomly assigned to receive either dapagliflozin or acetazolamide, and they can expect regular check-ins to monitor their health throughout the trial. This study is important because it could provide new insights into better ways to manage acute heart failure, potentially improving care for many patients.

Gender

ALL

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.

About Mansoura University

Mansoura University is a prestigious academic institution located in Egypt, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, it leverages its extensive resources and expertise in various fields of healthcare to facilitate innovative research initiatives aimed at improving patient outcomes. The university collaborates with a network of healthcare professionals and researchers to conduct high-quality clinical trials, focusing on addressing critical health challenges through rigorous scientific methodologies. Its dedication to ethical research practices and adherence to regulatory standards underscores its role as a leader in the medical research community.

Locations

Mansoura, , Egypt

Patients applied

0 patients applied

Trial Officials

Noha Mansour, PhD

Principal Investigator

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

Moheb Magdy Mouris, MD

Principal Investigator

Department of Cardiology, Faculty of Medicine, University of Mansoura

Mohamed El- Husseiny Shams, Professor

Study Chair

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported