RECRUITING

Empagliflozin in Patients With Cirrhosis and Ascites

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-11

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05726032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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 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. 10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks 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 2 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 \> or equal to 20 21. Hemoglobin \<8

Inclusion Criteria

Exclusion 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

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 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.
10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
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 2 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 \> or equal to 20
21. Hemoglobin \<8

Contacts and Locations

Study Contact

Veena Rao, PHD

CONTACT

2037373571

veena.s.rao@yale.edu

Kara Otis

CONTACT

2037373571

kara.otis@yale.edu

Principal Investigator

Jeffrey Testani, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Jeffrey Testani, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2023-09-11

Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

Cirrhosis
Liver Failure