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

NCT06919523 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-NM
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractory Ascites

Keywords

Refractory ascites; Dapagliflozin

Outcome Measures

Primary Outcomes (1)

• Difference in ascites control between the two groups at the end of treatment

  Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP.

  3 months

Study Arms (2)

Dapagliflozin group

EXPERIMENTAL

Drug: Dapagliflozin 5mg

Standard care only group

ACTIVE COMPARATOR

Drug: Standard care treatment

Interventions

Dapagliflozin 5mg DRUG

Dapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis)

Dapagliflozin group

Standard care treatment DRUG

Diuretics and Large volume paracentesis as indicated

Standard care only group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.
• Refractory ascites defined as one of the following:
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Ascites

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03