Digoxin for Alcoholic Hepatitis
(DIGIT-AlcHep Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including antiarrhythmics, parathyroid hormone analogs, thyroid supplements, sympathomimetics or ionotropic drugs, neuromuscular blocking agents, calcium supplements, ivabradine, and disulfiram.
Is digoxin generally safe for humans?
Digoxin has been used for many years, but it can be toxic if not dosed correctly, especially in people with liver or kidney problems. Women and older adults may be at higher risk for digoxin toxicity, which can lead to serious health issues. However, modern treatments can effectively manage toxicity if it occurs.12345
How does the drug digoxin differ from other treatments for alcoholic hepatitis?
Digoxin is unique because it targets a specific pathway (PKM2-HIF-1Ξ±) involved in liver inflammation and damage, which is different from other treatments for alcoholic hepatitis. It has been shown to reduce liver damage and inflammation in animal models, suggesting a novel approach compared to existing therapies.26789
Research Team
Bubu Banini, MD, PhD
Principal Investigator
Yale University
Eligibility Criteria
Adults aged 21-70 with severe acute alcohol-associated hepatitis can join this trial. They must have a history of regular heavy drinking and specific blood test results indicating liver damage. Excluded are pregnant or breastfeeding individuals, those allergic to digoxin, with certain infections including COVID-19, other liver diseases, HIV, cancer, serious heart conditions or on conflicting medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous digoxin dosed by weight and renal function for a maximum of 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Digoxin
Digoxin is already approved in European Union, United States, Canada, Japan for the following indications:
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor