Plain-English translation of NCT06613477 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is studying how digoxin, a heart medication, works in very young infants with a serious heart condition called single-ventricle heart disease. Researchers want to figure out the best dose of this medication for newborns and understand how their bodies process it. The study will help doctors treat these infants more safely and effectively.
Infants with single-ventricle heart disease need heart medication to help their hearts pump blood properly, but doctors don't have clear guidelines for the right doses in this very young population. This medication works differently in newborns than in older children and adults, so this study will provide the information needed to give the safest and most effective doses.
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Your infant will receive digoxin by mouth every 12 hours, with the dose carefully calculated based on their weight, age, and kidney function. You will make visits to the hospital or clinic where small blood samples will be taken at specific times (starting around day 7 and continuing through the study) to measure how much medication is in your infant's body and how their heart is responding. Your participation may last up to 6 months, ending either when your infant has their second surgery or at 6 months, whichever comes first.
AI-generated summary from trial data · Jul 7, 2026 · Not medical advice
United States