Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
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
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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