Actively Recruiting
Assessing Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients Hospitalized with Acute Heart Failure
Led by Mansoura University · Updated on 2025-01-20
100
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical outcomes of two medications, dapagliflozin and acetazolamide, in adults hospitalized with acute heart failure. This study aims to compare how well these drugs improve the body's fluid balance and reduce hospital stay length when added to standard loop diuretic therapy. The trial also assesses the safety of these treatments to better understand their potential roles in managing acute heart failure. Participants will receive either dapagliflozin 10 mg, a sodium-glucose cotransporter-2 inhibitor, or acetazolamide 500 mg, a carbonic anhydrase inhibitor, alongside their usual IV loop diuretic treatment. The study focuses on the early period after hospital admission, with randomization occurring within 24 hours. Both drugs are being studied to see how they affect symptoms and fluid removal during the hospitalization. During the study, researchers will measure participants' breathlessness using a visual scale from the start to day 3, among other clinical assessments. Participants must be adults hospitalized for fluid overload due to acute heart failure and will be monitored for kidney function and other safety markers. The study ensures close observation of drug effects and side effects throughout the hospital stay to provide detailed information on treatment impact and safety.
CONDITIONS
Official 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 who are hospitalized for hypervolemic acute heart failure with evidence of congestion, including at least two of the following: peripheral edema, ascites, jugular venous pressure > 10 mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound; or pulmonary capillary wedge pressure > 19 mmHg with physical exam signs of hypervolemia if pulmonary artery catheterization is available
- Randomized 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/1.73m2 by the MDRD equation
You will not qualify if you...
- Unable to follow instructions
- Treated with any proximal tubular diuretics
- Systolic blood pressure less than 90 mm Hg
- Estimated glomerular filtration rate (GFR) less than 20 ml per 1.73 m2 of body surface area
- Diagnosed with type 1 diabetes mellitus
- Dyspnea mainly due to non-cardiac causes
- Cardiogenic shock
- Acute coronary syndrome within 30 days before randomization
- Planned or recent percutaneous or surgical coronary intervention within 30 days before 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
AI-Screening
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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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