Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
NCT ID: NCT03877965
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2019-08-05
2022-01-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children with single ventricle congenital heart disease
Receiving digoxin per standard of care during the interstage period
Digoxin
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
Interventions
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Digoxin
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
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Inclusion Criteria
* 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 Criteria
* 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
6 Months
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The Emmes Company, LLC
INDUSTRY
Christoph P Hornik, MD MPH
OTHER
Responsible Party
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Christoph P Hornik, MD MPH
Associate Professor of Pediatrics
Principal Investigators
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Christoph Hornik, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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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
Countries
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Other Identifiers
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NICHD-2018-DGX01
Identifier Type: OTHER
Identifier Source: secondary_id
HHSN27500002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00102130
Identifier Type: -
Identifier Source: org_study_id
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