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Phase 1 Completed N=42 Single-blind Basic Science

Inhibition of Sterile Inflammation by Digoxin

Inflammatory Response
Source: ClinicalTrials.gov NCT03559868 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production		 — —
SECONDARY
Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro		 697; 1351; 5790; 1205; 12180; 22328 <0.01 sig

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03559868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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