Empagliflozin in Patients With Cirrhosis and Ascites

Launched by YALE UNIVERSITY · Feb 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called empagliflozin to see how it affects patients with cirrhosis and ascites, which is a condition where fluid builds up in the abdomen due to liver problems. The trial aims to understand how empagliflozin impacts the body's ability to get rid of salt and water, as well as its effects on kidney function and hormonal activity related to these conditions. It's important to note that this trial is in the early stages and is comparing the effects of empagliflozin with a placebo, which is a pill that does not contain any active medication.

To qualify for the study, participants must be at least 18 years old, have cirrhosis and ascites, and be on a stable dose of diuretics (medications that help remove excess fluid) without needing frequent procedures to remove fluid. Those interested in participating should be aware that certain health conditions and recent medical events may prevent them from being eligible. If you join the study, you can expect to take the study medication for 14 days and undergo regular check-ups to monitor your health throughout the trial. This research could help find new ways to manage fluid buildup in patients with liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses
• • 2. eGFR \>= 30mL/min/1.73 m2
• • 3. \>=18 years old
• Exclusion Criteria:
• • 1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)
• • 2. Direct bilirubin \>=3 mg/dL
• • 3. Systolic blood pressure \< 100 mmHg
• • 4. Active malignancy including hepatocellular carcinoma undergoing treatment
• • 5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
• • 6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance
• • 7. Type 1 diabetes
• • 8. History of frequent hypoglycemic episodes
• • 9. Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor.
• • 10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
• • 11. Hepatic encephalopathy grade II or greater at the time of enrollment
• • 12. Patients who have had TIPS placed
• • 13. Previous liver transplant
• • 14. Participation in another trial with an investigational drug within the 30 days prior to informed consent
• • 15. Pregnancy or breastfeeding
• • 16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)
• • 17. Change in diuretic dose in the prior 2 weeks
• • 18. Patients with hospitalization for alcoholic hepatitis in the past 6 months
• • 19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks
• • 20. MELD-Na \> or equal to 20
• • 21. Hemoglobin \<8