PK/PD of Digoxin in Infants With SVHD

Launched by DUKE UNIVERSITY · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the medication digoxin works in infants who have a specific heart condition called single ventricle heart disease. Digoxin is often given to help improve heart function in young children receiving care for heart issues. The researchers want to understand how the body processes this medication in infants and how it might help their hearts work better.

To participate, infants must be less than 6 months old and have undergone a certain heart surgery, but they cannot have been born prematurely or have certain other medical issues. If your child joins the study, their regular treatment won't change, but the researchers will collect blood samples during routine tests to gather information about how digoxin affects them. The study aims to keep risks low, but there may be concerns about privacy and the process of drawing blood. Overall, this study offers a chance to help improve understanding of heart treatments for infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of single ventricle congenital heart disease
• • 2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
• • 3. Age ≤ 30 days of life at time of stage 1 palliation
• • 4. Age \< 6 months at time of enrollment
• • 5. Require treatment with enteral digoxin per their treating medical provider
• • 6. Informed consent obtained from parent(s) or legal guardian(s)
• Exclusion Criteria:
• • 1. Prematurity (gestational age \<37 weeks) at birth
• • 2. Serum creatinine \> 2 mg/dL at enrollment
• • 3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment
• • 4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
• • 5. Known hypersensitivity to digoxin or other forms of digitalis
• • 6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
• • 7. Received digoxin prior to enrollment