Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Veena Rao, PHD
veena.s.rao@yale.edu
2037373571
Backup
Kara Otis
kara.otis@yale.edu
2037373571
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 20
Treatments
Active_comparator: Empagliflozin
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.
Placebo_comparator: Placebo
Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug.
Related Therapeutic Areas
Sponsors
Collaborators: Boehringer Ingelheim
Leads: Yale University