Status:
COMPLETED
Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
Lead Sponsor:
Christoph P Hornik, MD MPH
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 6 years
Brief Summary
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children \<6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior ...
Detailed Description
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded this protocol titled "Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle...
Eligibility Criteria
Inclusion
- Diagnosis of single ventricle congenital heart disease
- Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
- Age ≤ 30 days of life at time of stage 1 palliation
- Age \< 6 months at time of enrollment
- Require treatment with enteral digoxin per their treating medical provider if their planned maintenance treatment dosing regimen is within the labeled dose range of 7.5 - 20 mcg/kg/day divided in 2 or 3 equal doses
- Informed consent from parent(s) or legal guardian(s)
Exclusion
- Serum creatinine \> 2 mg/dL at enrollment
- Diagnosis of second degree or higher atrioventricular conduction block at enrollment
- Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
- Known hypersensitivity to digoxin or other forms of digitalis
- Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
- Received digoxin prior to enrollment
- Received or anticipated to receive a loading dose of digoxin.
- Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
Key Trial Info
Start Date :
August 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 17 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03877965
Start Date
August 5 2019
End Date
January 17 2022
Last Update
October 12 2022
Active Locations (11)
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1
Mattel Children's Hospital at UCLA
Los Angeles, California, United States, 90095
2
Rady Childrens Hospital and Health Center
San Diego, California, United States, 92123
3
The Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803