A Phase 3 clinical trial (NCT06535529) investigating dapagliflozin as an add-on treatment for acute decompensated heart failure (ADHF) patients reached its primary completion on 2025-08-01. This trial compares dapagliflozin to acetazolamide in patients with clinical signs of volume overload.
Background
Dapagliflozin is being investigated for its role in treating acute decompensated heart failure (ADHF). This condition affects adult patients with clinical signs of volume overload requiring intravenous loop diuretics.
Trial design
The study, titled "Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients" (NCT06535529), is a Phase 3 clinical trial. It has an estimated enrollment of 60 participants, focusing on adult patients with acute decompensated heart failure who exhibit clinical signs of volume overload and require intravenous loop diuretics. The trial compares the effectiveness of acetazolamide versus dapagliflozin 10mg as add-on therapies to standard care. The primary objectives include assessing which drug leads to a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and better loop diuretic efficiency, as measured by weight loss.
What this means
The primary completion of this Phase 3 trial indicates that data collection for the main outcomes comparing dapagliflozin and acetazolamide in acute decompensated heart failure patients has concluded. Researchers will now proceed with data analysis to determine the comparative effectiveness and safety profiles of these two treatments as add-ons to standard care. The findings are anticipated to provide important insights into managing volume overload in ADHF patients.
Source
The information regarding the primary completion of trial NCT06535529 was obtained from ClinicalTrials.gov, a public database of clinical studies. The event was recorded on 2025-08-01 on clinicaltrials.gov.