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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Number of times patient need Paracentesis to control Ascites [Time frame: 3 months]

Secondary outcome measures (1)

• incidence of Cirrhosis sequelae [Time frame: 3 months]

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

• Child Pugh score ≥ 12 or MELD score > 25.
• Previous history of hypoglycemia or has a previous history of DKA.
• Blood pressure less than 90/60 or need dose of midodrine >15 mg/day.
• 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.
• Pregnant or lactating female patients.
• Hypersensitivity to dapagliflozin.
• eGFR < 30 ml/min/1.73 m2
• Had hepatocellular carcinoma or any malignancy.
• Serum sodium level < 125 mg/dl.
• Portal vein thrombosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Egypt · 1 center

• Haram Hospital — Giza

Identifiers

NCT: NCT07684326 · F PH-BSU-HREC-0001625

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗