Empagliflozin in Patients With Cirrhosis and Ascites

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05726032
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cirrhosis
  • Liver Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    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.
  • Matching Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo) [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Katherine Keith

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CT

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