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Completed

NCT Number: NCT03559868

Inhibition of Sterile Inflammation by Digoxin

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.

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Key information

Conditions

Inflammatory Response

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale Centre of Clinical Investigation

New Haven, Connecticut, 06520, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digoxin

Drug

Participants will receive 3 mcg/Kg/day doses of oral digoxin

Placebo

Other

Oral placebo

Primary outcomes

  1. Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production

    Time frame: after starting digoxin

    Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.

  2. Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production

    Time frame: 1 week after starting digoxin

    Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.

  3. Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production

    Time frame: 2 weeks after starting digoxin

    Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.

  4. Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production

    Time frame: 3 weeks after starting digoxin

    Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.

Secondary outcomes

  1. Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro

    Time frame: 6 weeks

    Blood (25ml) will be obtained from healthy blood donors at one time. Human peripheral monocytes will be isolated using Polymorphprep™ density sedimentation according to the manufacturer's instructions. Data presented here are the mean concentrations.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2018
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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