Empagliflozin in Patients With Cirrhosis and Ascites
NCT05726032 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-19
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.
Conditions
- Cirrhosis
- Liver Failure
Interventions
- DRUG
-
Empagliflozin 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.
- DRUG
-
Matching 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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Yale University
lead OTHER
Principal Investigators
-
Jeffrey Testani, MD · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-11
- Primary Completion
- 2026-06-01
- Completion
- 2026-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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