Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
DGX01
3 other identifiers
observational
50
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2019
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 18, 2019
CompletedStudy Start
First participant enrolled
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedOctober 12, 2022
October 1, 2022
1.9 years
March 14, 2019
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma concentrations of digoxin
The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory.
Approximately 7 months
Secondary Outcomes (10)
Number of adverse events related to study procedures and serious, unexpected, suspected adverse reactions related to digoxin
Approximately 7 months
Tachyarrthmias
Approximately 7 months
Number of participants with second and third degree atrioventricular conduction block
Approximately 7 months
Number of participants with sinus bradycardia
Approximately 7 months
Number of participants with need for temporary or permanent pacing
Approximately 7 months
- +5 more secondary outcomes
Other Outcomes (25)
Plasma concentration of NT-proBNP
Approximately 7 months
Plasma concentration of MR-proANP
Approximately 7 months
Right ventricular or left ventricular end diastolic volume
Approximately 7 months
- +22 more other outcomes
Study Arms (1)
Children with single ventricle congenital heart disease
Receiving digoxin per standard of care during the interstage period
Interventions
Drug administered per standard of care, with a dosing regimen within the labeled dose range of 7.5-20 mcg/kg/day divided in 2 or 3 equal doses
Eligibility Criteria
Up to 48 infants diagnosed with single ventricle congenital heart disease, receiving digoxin per standard of care during the interstage period
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Mattel Children's Hospital at UCLA
Los Angeles, California, 90095, United States
Rady Childrens Hospital and Health Center
San Diego, California, 92123, United States
The Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Biospecimen
Blood samples will be collected to assess pharmacokinetic and biomarker levels
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Hornik, MD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 18, 2019
Study Start
August 5, 2019
Primary Completion
July 13, 2021
Study Completion
January 17, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share