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

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.

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Key information

Conditions

Refractory Ascites Ascites Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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.

Treatment and study plan

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

Primary outcomes

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

Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 9, 2025
Registry last updated: Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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