NCT06919523

Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. The main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as: Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. Researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.

Conditions

• Refractory Ascites

Interventions

Type	Name	Description
DRUG	Dapagliflozin 5mg	Dapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis)
DRUG	Standard care treatment	Diuretics and Large volume paracentesis as indicated

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-08-15
• Completion: 2025-09-15
• First posted: 2025-04-09
• Last updated: 2025-04-09