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

Phase 2

Not yet recruiting

• Conditions: Refractory Ascites
• Interventions: Drug: Dapagliflozin 5mg; Drug: Standard care treatment

• Registration Number: NCT06919523
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-04-15
• Primary Completion: 2025-08-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adults >18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.

• Refractory ascites defined as one of the following:

  1. Ascites cannot be mobilized despite adherence to low sodium diet of ≤88 mmol/day for ≥1 week and maximum diuretic treatment dose (spironolactone 400 mg/day or furosemide (160 mg/day).
  2. Recurrence can't be prevented by medical therapy, Re-appearance of grade 2 or moderate ascites with moderate symmetrical abdominal distention, or grade 3 with massive ascites with marked abdominal distention within 4 weeks of initial mobilization.

Exclusion Criteria

• Presenting blood pressure below 90/60 or history of hypotension requires vasopressor treatment.
• History of recurrent urinary tract infections, defined by the occurrence of 2 or more acute UTIs within months or 3 within a year.
• History of hypersensitivity to SGLT2 inhibitors.
• History of diabetic ketoacidosis or presence of risk factors for DKA (i.e alcohol consumption, type 1 diabetes).
• Pregnant or lactating women.
• History of recurrent episodes of hypoglycemia defined as plasma glucose concentration <70mg/dL.
• Severe renal dysfunction defined as, eGFR <20 ml/min/1.73m2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin group	Dapagliflozin 5mg	-
Standard care only group	Standard care treatment	-

Primary Outcome Measures

Name	Time	Method
Difference in ascites control between the two groups at the end of treatment	3 months	Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP.