Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID06783166

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

Led by Mansoura University · Updated on 2025-01-20

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing the effects of two medications, dapagliflozin and acetazolamide, in adults hospitalized with acute heart failure who show signs of fluid overload. This study aims to see which drug better improves fluid removal and breathing difficulty, as well as shortens hospital stays. Both drugs will be given alongside standard loop diuretic therapy, and their safety will be monitored to detect any side effects. The goal is to gather evidence that could help improve treatment for acute heart failure. Participants will be randomly assigned to receive either dapagliflozin 10 mg once daily or acetazolamide 500 mg once daily, both taken by mouth in addition to their usual loop diuretics and care for three days. This is a double-blind study, so neither the participants nor the researchers will know which treatment is given. The study begins shortly after hospital admission and treatments are given during the initial days of hospitalization. During the study, participants will be monitored closely for changes in their breathing difficulty using a visual scale from baseline to day three. Other health assessments and safety checks will be completed to track responses and any side effects. The overall hospital stay length and kidney function will also be observed. The total participation time covers the initial hospitalization period and follow-up assessments as scheduled by the study team.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older hospitalized for hypervolemic acute heart failure
  • Evidence of congestion with at least two signs or symptoms such as peripheral edema, ascites, jugular venous pressure > 10 mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or congestion on chest x-ray or lung ultrasound
  • If available, pulmonary artery catheterization showing pulmonary capillary wedge pressure > 19 mmHg plus systemic hypervolemia signs
  • Randomization within 24 hours of hospitalization for acute heart failure
  • Planned use of intravenous loop diuretic therapy during current hospitalization
  • Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73 m2 by the MDRD equation
Not Eligible

You will not qualify if you...

  • Unable to follow instructions
  • Treatment with any proximal tubular diuretics
  • Systolic blood pressure less than 90 mm Hg
  • Estimated glomerular filtration rate less than 20 ml/min/1.73 m2
  • Type 1 diabetes mellitus
  • Dyspnea primarily caused by non-cardiac issues
  • Cardiogenic shock
  • Acute coronary syndrome within 30 days before randomization
  • Planned or recent coronary intervention within 30 days before randomization
  • Signs of ketoacidosis or hyperosmolar hyperglycemic syndrome
  • Pregnant or nursing (lactating) women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - 3 days

Participants receive once daily dapagliflozin 10 mg or acetazolamide 500 mg orally in addition to loop diuretic therapy and standard care.

Daily visits for 3 days

Trial Site Locations

Total: 1 location

1

Noha Mansour

Al Mansurah, Egypt, 35516

Actively Recruiting

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Research Team

H

Hossameldin Sharaf, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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