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Recruiting NCT05726032

Empagliflozin in Patients With Cirrhosis and Ascites

Phase II Interventional Cirrhosis Liver Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin 10 MG, Matching Placebo.
Who it may be relevant to
Registry conditions: Cirrhosis, Liver Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites

Overview

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.

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.

Primary outcome measures

  • Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo) [Time frame: 14 days]
  • Change in total body water (TBW) before and after a 14-day course of study drug [Time frame: 14 days]
Secondary outcome measures (2)
  • Change in renal blood flow before and after administration of study drug [Time frame: Baseline to Hour 6]
  • Change in plasma renin activity,total renin, aldosterone, norepinephrine and copeptin [Time frame: 14 days]

Eligibility criteria

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
  • Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor.
  • Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
  • Hepatic encephalopathy grade II or greater at the time of enrollment
  • Patients who have had TIPS placed
  • Previous liver transplant
  • Participation in another trial with an investigational drug within the 30 days prior to informed 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
  • Patients with hospitalization for alcoholic hepatitis in the past 6 months
  • Significant worsening of creatinine (more than 50% increase) in the past 4 weeks
  • MELD-Na > or equal to 20
  • Hemoglobin <8

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Yale University — New Haven

Identifiers

NCT: NCT05726032 · 2000034606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗