Digoxin In Treatment of Alcohol Associated Hepatitis

Description

Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, digoxin administration and dose adjustment. The study intervention will be intravenous digoxin (renal-based dosing for maximum of 28 days) versus no digoxin in an open-label 1:1 randomized allocation of patients with severe acute alcohol associated hepatitis.

Conditions

Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders, Steatohepatitis Caused by Ingestible Alcohol

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Study Overview

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Study Details

Study overview

Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, digoxin administration and dose adjustment. The study intervention will be intravenous digoxin (renal-based dosing for maximum of 28 days) versus no digoxin in an open-label 1:1 randomized allocation of patients with severe acute alcohol associated hepatitis.

Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)

Digoxin In Treatment of Alcohol Associated Hepatitis

Condition
Acute Alcoholic Hepatitis
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, Yale School of Medicine, New Haven, Connecticut, United States, 06510

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosis of alcohol associated hepatitis based on clinical criteria or histologic evidence
  • 1. Clinical criteria:
  • * Onset of jaundice (bilirubin \>3 mg/dL) within the prior 8 weeks
  • * Regular alcohol use \> 6 months, with intake of \> 40 g/day (\>280 g/week) for women; and \> 60 g/day (\>420 g/week) for men
  • * AST \> 50 IU/l
  • * AST: ALT \> 1.5 and both values \< 400 IU/l
  • 2. Histological evidence of alcohol associated hepatitis\*
  • 2. MDF \>32 or MELD ≥ 20 to ≤ 35 on Day 0 of the trial
  • 3. Age between 21 and 70 years, inclusive
  • 1. - Currently pregnant or breastfeeding
  • 2. - Inability of patient, legally authorized representative or next-of-kin to provide informed consent
  • 3. - Allergy or intolerance to digoxin
  • 4. - Clinically active C. diff infection
  • 5. - Positive test for COVID-19 within 14 days prior to the screening visit
  • 6. - Acute hepatitis E, Cytomegalovirus, Epstein Barr Virus, Herpes Simplex Virus
  • * Antiarrhythmic (amiodarone, dofetilide, sotalol, dronedarone)
  • * Parathyroid hormone analog (teriparatide)
  • * Thyroid supplement (thyroid, levothyroxine sodium)
  • * Sympathomimetics or ionotropic drugs (epinephrine, norepinephrine, dopamine, dobutamine, milrinone)
  • * Neuromuscular blocking agents (succinylcholine)
  • * Calcium supplement
  • * Ivabradine
  • * Disulfiram

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Bubu Banini, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

2025-04