"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"

This study aims to evaluate beneficial effects of using dapagliflozin in cirrhotic chronic liver disease patients. We hypnotized that the use of dapagliflozin will be associated with fewer need for large volume paracentesis hence better control of ascites, fewer need for ICU admissions, improvement of patient quality of life, better healthcare cost saving and reduced mortality rate.

Study Overview

• Status: Recruiting
• Conditions: Ascites Hepatic
• Intervention / Treatment: Drug: Dapagliflozin

Detailed Description

Patients diagnosed with cirrhosis and any degree of ascites that led to previous or recent hospital admission and met the inclusion criteria will be randomized into two patient groups. The first patients' group, Group A, will receive standard of care (SoC) regimen only. The SoC included dietary sodium restriction, treatment with diuretics [combination of a loop diuretic (furosemide 40-160 mg/day or torsemide 5-20 mg/day) and a distal-acting diuretic (spironolactone 50-400 mg/day)] and LVP as needed. The second patients' group, group B, will receive dapagliflozin in addition to standard of care regimen. Based on the pharmacokinetic data of dapagliflozin; Patient with Child Pugh score A and B will receive 10mg/day and patients with Child Pugh score C will receive 5 mg/day. Patients will be counseled to stay adequately hydrated and avoid alcohol intake at baseline and at every follow-up visit. Adherence, body weight, symptoms of urinary tract infection, and Sodium level will be measured after 1 and 2 weeks from the start of the therapy then at the end of the follow-up period. At the start of participation and at the end of follow up period, a quality of life will be assessed using quality of life questionnaire for chronic liver disease patients. The patient will be interviewed by the principal investigator to fill the questionnaire to ensure understanding of each question.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Raghda Roshdy; Phone Number: +0282-2162135; Email: Raghda.hussien@pharm.bsu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12556
    • Recruiting
    • Haram Hospital
    • Contact: asia said; Email: asia_said@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study.

Exclusion Criteria:

1. Child Pugh score ≥ 12 or MELD score > 25.
2. Previous history of hypoglycemia or has a previous history of DKA.
3. Blood pressure less than 90/60 or need dose of midodrine >15 mg/day.
4. Previous history of recurrent urinary tract infections (more than 2 infections in the last 6 months) or anatomic urologic defects that predispose to urinary tract infection.
5. Pregnant or lactating female patients.
6. Hypersensitivity to dapagliflozin.
7. eGFR < 30 ml/min/1.73 m2
8. Had hepatocellular carcinoma or any malignancy.
9. Serum sodium level < 125 mg/dl.
10. Portal vein thrombosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; Patients will receive standard of care (SoC) regimen only. The SoC included dietary sodium restriction, treatment with diuretics [combination of a loop diuretic (furosemide 40-160 mg/day or torsemide 5-20 mg/day) and a distal-acting diuretic (spironolactone 50-400 mg/day)] and large volume paracentesis as needed.
Experimental: Group B; Patients will receive dapagliflozin in addition to standard of care regimen. Based on the pharmacokinetic data of dapagliflozin; Patient with Child Pugh score A and B will receive 10mg/day and patients with Child Pugh score C will receive 5 mg/day.	Drug: Dapagliflozin; Dapagliflozin is sodium glucose cotransporter type 2 inhibitors (SGLT-2i) primary an antidiabetic drug but now used in chronic heart failure and chronic kidney disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times patient need Paracentesis to control Ascites	Decrease need for large volume paracentesis in the intervention group than in the control group which indicate better control of Ascites within 3 months from the start of intervention.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Cirrhosis sequelae	• Reduced incidence of Cirrhosis sequelae (hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, variceal bleeding) in the intervention group as compared to control group.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life using SF-36 questionnaire	• Improvement of patient quality of life in the intervention group as compared to control group.	3 months

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: dapagliflozin
• Other Study ID Numbers: F PH-BSU-HREC-0001625

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No