Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06783166

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dapagliflozin 10mg

Drug

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

Acetazolamide 500mg

Drug

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

Primary outcomes

  1. Change in dyspnea VAS (Visual analogue scale)

    Time frame: From baseline to day 3

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hossameldin Sharaf, BSc

CONTACT

[email protected]

+201009648197

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.