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

NCT ID: NCT06919523

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-09-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dapagliflozin group

Group Type: EXPERIMENTAL

Dapagliflozin 5mg

Intervention Type: DRUG

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

Standard care only group

Group Type: ACTIVE_COMPARATOR

Standard care treatment

Intervention Type: DRUG

Diuretics and Large volume paracentesis as indicated

Interventions

Dapagliflozin 5mg

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

Intervention Type: DRUG

Standard care treatment

Diuretics and Large volume paracentesis as indicated

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Noha Mansour

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025-NM

Identifier Type: -

Identifier Source: org_study_id