RECRUITING

Digoxin In NASH (CODIN)

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

Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.

Official Title

Clinical Trial of Oral Digoxin In NASH (CODIN)

Quick Facts

Study Start:2025-06-05
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06588699

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Bubu Banini, MD, PhD
CONTACT
203-737-6063 or 203-215-7749
bubu.banini@yale.edu
Tara McPartland
CONTACT
tara.mcpartland@yale.edu

Principal Investigator

Bubu A Banini, MD, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Health
New Haven, Connecticut, 06510
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Bubu A Banini, MD, PhD, 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 Date2025-06-05
Study Completion Date2029-01

Study Record Updates

Study Start Date2025-06-05
Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

  • NASH
  • MASH
  • Metabolic dysfunction associated steatohepatitis
  • Digoxin
  • Drug repurposing
  • Liver fibrosis
  • Fatty liver disease
  • NAFLD

Additional Relevant MeSH Terms

  • NASH
  • NAFLD
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis
  • Mash
  • MASH With Fibrosis
  • MASLD
  • Fatty Liver Disease
  • Fatty Liver Disease, Nonalcoholic