Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease

Completed

Conditions studied: Congenital Heart Disease

In brief

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 to surgical stage 2 palliation.

Key facts

Study ID

NCT03877965

Run by

Christoph P Hornik, MD MPH

People needed

50

Starts

2019-08-05

Expected to finish

2022-01-17

Last updated by the study team

2022-10-12

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mattel Children's Hospital at UCLA — Los Angeles, California, United States
• Rady Childrens Hospital and Health Center — San Diego, California, United States
• The Children's Hospital Colorado — Aurora, Colorado, United States
• Alfred I. DuPont Hospital for Children — Wilmington, Delaware, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Morgan Stanley Children's Hospital of New York Presbyterian — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Children's Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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