Empagliflozin in Patients With Cirrhosis and Ascites
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Empagliflozin 10 MG
- Matching Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Boehringer Ingelheim
Collaborator
Source ClinicalTrials.gov