Inhibition of Sterile Inflammation by Digoxin

  • STATUS
    Recruiting
  • End date
    Jul 28, 2023
  • participants needed
    45
  • sponsor
    Yale University
Updated on 25 June 2021

Summary

To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.

Description

To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin.

To investigation of how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.

Details
Condition Inflammatory Response, inflammatory responses
Treatment Placebo, Digoxin
Clinical Study IdentifierNCT03559868
SponsorYale University
Last Modified on25 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >18 y 70 years
subjects with normal serum creatinine, normal EKG and currently not taking any medication

Exclusion Criteria

Autoimmune liver disease (ANA > 1/320)
Chronic viral hepatitis
Hepatocellular carcinoma
Complete portal vein thrombosis
Extrahepatic terminal disease
Pregnancy
Treatment with prednisolone or pentoxifyllin for more than 3 days prior to inclusion/start date
Active alcohol abuse (>50 g/day for men and >40 g/day for women) in the last 3 months
AST > ALT and total bilirubin > 3 mg/dl in the past 3 months
Liver biopsy and/or clinical picture consistent with alcoholic hepatitis
Lack of signed informed consent
Known hypersensitivity to digoxin or other forms of digitalis, ventricular fibrillation
Any significant medical conditions, any electrolyte abnormalities, over the counter medications, natural products and prescription drugs
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