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

CompletedOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

August 5, 2019

Primary Completion Date

July 13, 2021

Study Completion Date

January 17, 2022

Conditions
Congenital Heart Disease
Interventions
DRUG

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

Trial Locations (11)

10032

Morgan Stanley Children's Hospital of New York Presbyterian, New York

19803

Alfred I. DuPont Hospital for Children, Wilmington

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

33155

Nicklaus Children's Hospital, Miami

63110

St. Louis Children's Hospital, St Louis

77030

Children's Memorial Hermann Hospital, Houston

80045

The Children's Hospital Colorado, Aurora

90095

Mattel Children's Hospital at UCLA, Los Angeles

92123

Rady Childrens Hospital and Health Center, San Diego

45229-3039

Cincinnati Childrens Hospital Medical Center, Cincinnati

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

Christoph P Hornik, MD MPH

OTHER

NCT03877965 - Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease | Biotech Hunter | Biotech Hunter