Study of Digoxin Medication Effects in Infants Under 6 Months With Single Ventricle Heart Disease After First Surgery

What this Trial Is About

Researchers are studying infants with single ventricle congenital heart disease who have undergone the first stage of surgical or hybrid palliation but are awaiting the second stage. This research focuses on how the medication digoxin, commonly prescribed in pediatric cardiac intensive care units, is processed by the body and its potential effects on heart function. The study aims to validate a dosing model designed specifically for this infant population to ensure appropriate digoxin exposure. Participants will receive digoxin elixir administered orally every 12 hours, with dosing determined by a population-specific pharmacokinetic model that considers weight, postnatal age, and kidney function. Digoxin levels in the blood will be measured at several specific times, including trough and post-dose levels on designated days throughout the study, which can last up to 180 days or until the second stage of palliation. Blood samples to assess pharmacodynamic markers related to heart function will also be collected at set intervals. During the study, researchers will gather blood samples opportunistically when routine bloodwork is performed and review medical records including echocardiograms and cardiac catheterizations obtained as part of standard care. Safety will be monitored by tracking adverse events related to digoxin and study procedures. The primary outcome is the concentration of digoxin in the plasma by the end of the study period. Participation will last up to 180 days, with careful monitoring to minimize risks associated with blood draws and data confidentiality.

PK/PD of Digoxin in Infants With SVHD