Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
- Registration Number
- NCT03877965
- Lead Sponsor
- Christoph P Hornik, MD MPH
- 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 to surgical stage 2 palliation.
- 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 Congenital Heart Disease", protocol number NICHD-2018-DGX01. The Investigational New Drug (IND) Sponsor and Principal Investigator for this protocol is Christopher P. Hornik, MD, MPH. The Contracting Officer's Technical Representative (COTR) to represent the Government for this task order is Perdita Taylor-Zapata. The Duke IRB number for this study is Pro00102130. This study employs a central IRB, the WIRB-Copernicus Group (WCG). The c-IRB (WCG) study number is 20190888 / NICHD-2018-DGX01.
This is a prospective, multicenter Phase 1 study with a primary objective to characterize the pharmacokinetics of enteral digoxin in infants with single ventricle congenital heart disease. The secondary objective is to determine the safety profile of enteral digoxin in infants with single ventricle congenital heart disease. Digoxin is used for the treatment of heart failure in pediatric patients and acts by controlling numerous functions of the cardiovascular system. Digoxin use in single ventricle congenital heart disease may decrease interstage mortality.
The study will be conducted in approximately 48 subjects at approximately 13 investigational centers. The proposed duration of the study is approximately 196 (±) days.
Please see the protocol and synopsis for more information.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children with single ventricle congenital heart disease Digoxin Receiving digoxin per standard of care during the interstage period
- Primary Outcome Measures
Name Time Method Plasma concentrations of digoxin Approximately 7 months The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory.
- Secondary Outcome Measures
Name Time Method QRS duration Approximately 7 months Derived from electrocardiograms and their reports performed per standard of care
Number of participants with second and third degree atrioventricular conduction block Approximately 7 months PR interval Approximately 7 months Derived from electrocardiograms and their reports performed per standard of care
Number of adverse events related to study procedures and serious, unexpected, suspected adverse reactions related to digoxin Approximately 7 months 1. Adverse events (AEs) related to the study procedures (blood draws and outcome assessments), and serious, unexpected, suspected adverse reactions (SUSARs) related to digoxin will be captured.
Number of participants with sinus bradycardia Approximately 7 months Number of participants with sinus bradycardia
Tachyarrthmias Approximately 7 months Event of special interest will be captured (number of tachyarrythmias)
Number of participants with need for temporary or permanent pacing Approximately 7 months Number of participants with need for temporary or permanent pacing
Frequency of death Approximately 7 months Frequency of death
QT interval Approximately 7 months Derived from electrocardiograms and their reports performed per standard of care
Corrected QT interval using Bazett's formula Approximately 7 months Derived from electrocardiograms and their reports performed per standard of care
Trial Locations
- Locations (11)
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Morgan Stanley Children's Hospital of New York Presbyterian
🇺🇸New York, New York, United States
The Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Rady Childrens Hospital and Health Center
🇺🇸San Diego, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Mattel Children's Hospital at UCLA
🇺🇸Los Angeles, California, United States
Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States