Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease

Study characterizing pharmacokinetics and safety of enteral digoxin used in infants with single ventricle congenital heart disease (CHD) 

Summary

Each year 40,000 infants born in the US are diagnosed with CHD. Single ventricle CHD is the most serious and complex form of the disease. While digoxin has been approved by the U.S. Food and Drug Administration for the treatment of heart failure in children and adults, more information is needed, particularly in children with single ventricle CHD. The team conducting this research hopes that the information collected in this study will help doctors improve the dosing of digoxin in children who have single ventricle CHD in the future. This study aims to enroll up to 48 infants diagnosed with single ventricle CHD, receiving digoxin per standard of care during the interstage period.

 

OVERVIEW

Status:
Enrollment to start

ClinicalTrials.gov Identifier:
NCT03877965

Principal Investigator:
Christoph Hornik, MD
Duke Health, Durham, NC

NEWS

  • First participant enrolled in digoxin study September 5, 2019 The PTN digoxin study achieved a major study milestone by enrolling its first participant. The study team aims to enroll up to 48 infants to determine the pharmacokinetics (how a drug travels through the body) and safety of digoxin prescribed to infants with single ventricle congenital heart disease (CHD). While digoxin has been approved by the ...