Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease (DGX01)

Christoph P Hornik, MD MPH

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Drug: Digoxin

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT03877965

NICHD-2018-DGX01 (Other Identifier)

HHSN27500002 (Other Grant/Funding Number)

Pro00102130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Children with single ventricle congenital heart disease

Description:

Receiving digoxin per standard of care during the interstage period

Treatment:

Drug: Digoxin