Empagliflozin in Patients With Cirrhosis and Ascites

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

1. 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

2. eGFR >= 30mL/min/1.73 m2

3. >=18 years old

Exclusion Criteria:

1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)

2. Direct bilirubin >=3 mg/dL

3. Systolic blood pressure < 100 mmHg

4. Active malignancy including hepatocellular carcinoma undergoing treatment

5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections

6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance

7. Type 1 diabetes

8. History of frequent hypoglycemic episodes

9. Use of a non-loop diuretic aside from aldosterone antagonists 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.

10. Hepatic hydrothorax

11. Hepatic encephalopathy grade II or greater at the time of enrollment

12. Patients who have had TIPS placed

13. Previous liver transplant

14. Participation in another trial with an investigational drug within the 30 days prior to informed consent

15. Pregnancy or breastfeeding

16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)

17. Change in diuretic dose in the prior 4 weeks

18. Patients with hospitalization for alcoholic hepatitis in the past 6 months

19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks

20. MELD-Na <20