Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Egypt
Haram Hospital
RECRUITING
Giza
Contact Information
Primary
Raghda Roshdy
Raghda.hussien@pharm.bsu.edu.eg
+0282-2162135
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2027-09
Participants
Target number of participants: 52
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Beni-Suef University