Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05726032

Empagliflozin in Patients With Cirrhosis and Ascites

Led by Yale University · Updated on 2026-02-19

20

Participants Needed

1

Research Sites

142 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

B

Boehringer Ingelheim

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Empagliflozin in Patients With Cirrhosis and Ascites

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines) and who do not require large volume paracenteses
  • Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • 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 level of 3 mg/dL or higher
  • Systolic blood pressure less than 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
  • Use of non-loop diuretics other than aldosterone antagonists or amiloride
  • Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
  • Hepatic encephalopathy grade II or greater at the time of enrollment
  • Patients who have had transjugular intrahepatic portosystemic shunt (TIPS) placed
  • Previous liver transplant
  • Participation in another investigational drug trial within 30 days prior to consent
  • Pregnancy or breastfeeding
  • Inability to give written informed consent or follow study protocol (e.g., clinically significant psychiatric, addictive, or neurological disease)
  • Change in diuretic dose in the prior 2 weeks
  • Hospitalization for alcoholic hepatitis in the past 6 months
  • Significant worsening of creatinine (more than 50% increase) in the past 4 weeks
  • MELD-Na score of 20 or higher
  • Hemoglobin less than 8 g/dL

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06510

Actively Recruiting

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Research Team

V

Veena Rao, PHD

CONTACT

K

Kara Otis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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