Actively Recruiting
Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites
Led by Yale University · Updated on 2026-02-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Empagliflozin in Patients With Cirrhosis and Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone with or without loop-diuretics) 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
You will not qualify if you...
- Hospitalization for cirrhosis complications within the past 8 weeks (such as variceal bleeding, encephalopathy, acute kidney injury, or spontaneous bacterial peritonitis)
- Direct bilirubin level 3 mg/dL or higher
- Systolic blood pressure below 100 mmHg
- Active cancer including hepatocellular carcinoma under treatment
- History of bladder problems, incontinence, kidney infections, or frequent urinary tract infections
- Use of SGLT-2 inhibitors in the last 10 days or prior intolerance to these drugs
- Type 1 diabetes
- Frequent episodes of low blood sugar
- Use of non-loop diuretics other than aldosterone antagonists or amiloride
- Hepatic hydrothorax requiring thoracentesis in the past 8 weeks
- Hepatic encephalopathy grade II or higher at enrollment
- Previous transjugular intrahepatic portosystemic shunt (TIPS) placement
- Prior liver transplant
- Participation in another investigational drug trial within 30 days before consent
- Pregnancy or breastfeeding
- Inability to provide informed consent or follow study procedures due to psychiatric, addictive, or neurological conditions
- Change in diuretic dose in the last 2 weeks
- Hospitalization for alcoholic hepatitis in the past 6 months
- Significant worsening of kidney function (more than 50% increase in creatinine) in the past 4 weeks
- Model for End-Stage Liver Disease Sodium (MELD-Na) score 20 or higher
- Hemoglobin level below 8
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive Empagliflozin 10 mg or placebo for 14 days, followed by a 14 day washout period, then cross over to the alternate treatment for 14 days.
Visits at the start and end of each 14-day treatment period
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
V
Veena Rao, PHD
K
Kara Otis
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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