Inhibition of Sterile Inflammation by Digoxin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-05-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Inflammatory Response

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Digoxin 3 mcg/Kg/day

Patients receiving oral digoxin 3 mcg/Kg/day

Group Type ACTIVE_COMPARATOR

Digoxin

Intervention Type DRUG

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

Digoxin 0.15 mcg

Patients receiving oral digoxin 0.15 mcg/Kg/day

Group Type ACTIVE_COMPARATOR

Digoxin

Intervention Type DRUG

Participants will receive 0.15 mcg/Kg/day doses of oral digoxin

Placebo

oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral placebo

Interventions

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Digoxin

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

Intervention Type DRUG

Placebo

Oral placebo

Intervention Type OTHER

Digoxin

Participants will receive 0.15 mcg/Kg/day doses of oral digoxin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 y ≤ 70 years
2. subjects with normal serum creatinine, normal EKG and currently not taking any medication.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes