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NCT05726032PHASE2Recruiting

Empagliflozin in Patients With Cirrhosis and Ascites

Yale University

Start Date

9/11/2023

Completion Date

6/1/2026

Summary

A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Empagliflozin 10 MG

DRUG

Matching Placebo

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Conditions

CirrhosisLiver Failure

Locations

Yale University

New Haven, Connecticut 06510

United States