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

Christoph P Hornik, MD MPH50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Heart Disease

Interventions

DigoxinDRUG

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

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Locations (11)

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

Outcomes

Primary Outcomes

Plasma concentrations of digoxin

The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory.