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Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 15, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07076615). This is a study registration, not published results. Lead sponsor: May Mohamed Abdalla. Recruitment status: COMPLETED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 100 participants (ACTUAL). Conditions: Acute Decompensated Heart Failure (ADHF). Interventions: DRUG: Dapagliflozin (DAPA); DRUG: Diuretic. Primary outcome measures: Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS) , Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission). Brief summary: This randomized controlled trial evaluates the efficacy and tolerability of early initiation of dapagliflozin in adult patients hospitalized with acute heart failure (AHF). The study aims to assess the effect of dapagliflozin on pulmonary congestion as measured by lung ultrasound (LUS), length of hospital stay, and cardiac and renal biomarkers. A total of 100 patients will be randomized into two groups: one receiving dapagliflozin plus diuretics and the other receiving diuretics alone. Key outcomes include the reduction of extravascular lung water (assessed by B-lines in LUS), improved diuretic response, changes in NT-proBNP, sST2, CA-125, and NGAL levels, and incidence of acute kidney injury. The study will be conducted at the Cardiology and ICU departments at Kasr Al Ainy Hospital, Cairo University