Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin 10mg, Acetazolamide 500mg.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Dapagliflozin 10mg
Dapagliflozin 10 mg is a medication classified as a sodium-glucose cotransporter-2 (SGLT-2) inhibitor. - Drug Acetazolamide 500mg
Acetazolamide 500 mg is a medication classified as a carbonic anhydrase inhibitor.
Primary outcome measures
- Change in dyspnea VAS (Visual analogue scale) [Time frame: From baseline to day 3]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Noha Mansour — Al Mansurah
Identifiers
NCT: NCT06783166 · MS.24.04.2757