Study of Empagliflozin Effects on Fluid Balance and Kidney Function in Adults With Cirrhosis and Ascites

What this Trial Is About

Researchers are evaluating the effects of empagliflozin, a drug, on patients with cirrhosis and ascites. This proof-of-concept, placebo-controlled trial aims to explore how empagliflozin affects natriuresis sodium excretion and total body water over 14 days. The study also investigates its impact on neurohumoral activation and kidney blood flow in this patient group. Participants will be randomly assigned to receive either 10 mg of empagliflozin or a matching placebo for 14 days. After this treatment period, there will be a 14-day washout phase before participants switch to the alternate study drug for another 14 days. This crossover design allows comparison of empagliflozin and placebo effects within the same individuals. During the study, participants will undergo assessments to measure changes in sodium excretion and total body water at 14 days, as well as kidney blood flow and hormone levels from baseline to 6 hours and over 14 days. The study includes monitoring for safety and other health parameters. The total participation time covers the two treatment periods and the washout phase, lasting about 6 weeks in total.

Empagliflozin in Patients With Cirrhosis and Ascites