Empagliflozin in Patients With Cirrhosis and Ascites (EMPA Liver)
Cirrhosis, Liver Failure
About this trial
This is an interventional other trial for Cirrhosis
Eligibility Criteria
Inclusion Criteria: 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 eGFR >= 30mL/min/1.73 m2 >=18 years old Exclusion Criteria: Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis) Direct bilirubin >=3 mg/dL Systolic blood pressure < 100 mmHg Active malignancy including hepatocellular carcinoma undergoing treatment History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance Type 1 diabetes History of frequent hypoglycemic episodes Use of a non-loop diuretic aside from aldosterone antagonists 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. Hepatic hydrothorax Hepatic encephalopathy grade II or greater at the time of enrollment Patients who have had TIPS placed Previous liver transplant Participation in another trial with an investigational drug within the 30 days prior to informed consent Pregnancy or breastfeeding Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease) Change in diuretic dose in the prior 4 weeks Patients with hospitalization for alcoholic hepatitis in the past 6 months Significant worsening of creatinine (more than 50% increase) in the past 4 weeks MELD-Na <20
Sites / Locations
- Yale UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Empagliflozin
Placebo
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.