Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
Yale University
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DrugEmpagliflozin 10 MG
Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.
- DrugMatching Placebo
Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days.
Location
- Yale UniversityNew Haven, Connecticut