Phase
Condition
Scar Tissue
Liver Disorders
Liver Failure
Treatment
Empagliflozin 10 MG
Matching Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 volumeparacenteses
eGFR >= 30mL/min/1.73 m2
>=18 years old
Exclusion
Exclusion Criteria:
Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g.variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterialperitonitis)
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 frequenturinary 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 or amiloride as theyare not standard of care in patients with cirrhosis and could potentially increasethe risk of hypovolemia when combined with the standard treatment for ascites alongwith SGLT2 inhibitor.
Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
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 priorto 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 2 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 > or equal to 20
Hemoglobin <8
Study Design
Connect with a study center
Yale University
New Haven, Connecticut 06510
United StatesActive - Recruiting
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