RecruitingPhase 2

Empagliflozin in Patients With Cirrhosis and Ascites

United States20 participantsStarted 2023-09-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
✕. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance
✕. Type 1 diabetes
✕. History of frequent hypoglycemic episodes

What they're measuring

Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)

Timeframe: 14 days

Change in total body water (TBW) before and after a 14-day course of study drug

Timeframe: 14 days

Trial details

NCT IDNCT05726032

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Veena Rao, PHD

2037373571 veena.s.rao@yale.edu

View on ClinicalTrials.gov More Cirrhosis trials