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

NCT07684326

RecruitingPhase 2, Phase 3

Sponsor: Beni-Suef University

Conditions: Ascites Hepatic

Interventions: Dapagliflozin

Countries: Egypt

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Giza, Egypt