Digoxin Dosing in Infants with Single Ventricle Heart Disease
This study is for infants aged 30 days to 6 months with single ventricle heart disease (a complex heart condition). It aims to understand how the heart medication digoxin is processed by their bodies and how it helps their heart function. Researchers will collect blood samples during routine blood tests and gather information from medical records. Your child will receive digoxin as prescribed by their doctor, and this study will not change their treatment plan. The study will measure digoxin levels in the blood to see how the body handles the medication. There are some risks, like loss of privacy and discomfort from blood draws, but the study team will work to minimize these.
- Study design
- This is a multi-center, open-label study with 20 participants. It is designed to observe how digoxin is processed in infants.
- What's involved
- Your child would participate for up to 180 days. Blood samples will be collected at specific times after digoxin doses, often during routine blood draws.
- Compensation
- Not stated in the trial record.
- Follow-up
- Digoxin plasma concentration will be measured at the end of the study, up to 180 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PK/PD of Digoxin in Infants With SVHD
At a glance
Conditions
NCT06613477
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Medical Center
Durham, North Carolinano site contact published
Medical University of South Carolina
Charleston, South Carolinano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Christoph Hornik, MD · PRINCIPAL_INVESTIGATOR · Duke Clinical Research Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Digoxin plasma concentrationEnd of study, up to 180 Days
Plasma concentrations of digoxin over time measured using a validated bioanalytical assay at a central laboratory to calculate clearance and area under the curve (AUC)