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

Conditions

• Refractory Ascites

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 15, 2025

Status verified

Mar 2025

Primary completion

Aug 15, 2025

Completion

Sep 15, 2025

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dapagliflozin group
• Active Comparator: Standard care only group

Primary Outcome Measure

Difference in ascites control between the two groups at the end of treatment [ Time Frame: 3 months ]