PK/PD of Digoxin in Infants With SVHD

NCT06613477 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: Pro001132131R01HD106588-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function. The investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care ("opportunistic"). The investigators will also collect information from medical records. Being part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.

Conditions

Single-ventricle; Infant Conditions; Infant, Newborn, Diseases; Infant, Premature, Diseases

Keywords

Infants; SVD; SVHD; Single Ventricle; Digoxin; Pharmacokinetics; Pharmacodynamics; PK; PD

Outcome Measures

Primary Outcomes (1)

• Digoxin plasma concentration

  Plasma concentrations of digoxin over time measured using a validated bioanalytical assay at a central laboratory to calculate clearance and area under the curve (AUC)

  End of study, up to 180 Days

Study Arms (1)

Population specific PK model-derived digoxin dosing

EXPERIMENTAL

Digoxin elixir will be used to dose enterally every 12 hours. The dosage will be determined by the protocol PK model. Dosing is to be administered based on weight, postnatal age, and estimated glomerular filtration rate The duration of the participation could be up to 180 days. Day 1 to S2P or Day 180 (+/- 7)

Drug: PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease

Interventions

PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease DRUG

Table 3: Digoxin dosing regimen based on optimized Cmin,ss Dose to be given twice daily (mcg/kg/dose) PNA\<30 days 30 days \< PNA \< 180 days eGFR≤40 1.4 1.4 40\<eGFR≤60 1.6 1.6 eGFR\>60 1.9 2.8

Also known as: Lanoxin

Population specific PK model-derived digoxin dosing

Eligibility Criteria

• Age: 30 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• Informed consent obtained from parent(s) or legal guardian(s)

You may not qualify if:

• Gestational age at birth \<35 weeks
• 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
• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study

Sponsors & Collaborators

• Medical University of South Carolina: collaborator
• Duke Clinical Research Institute: collaborator
• National Center for Child Health and Development (NICHD): collaborator
• Duke University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27701, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Univentricular Heart; Infant, Newborn, Diseases; Infant, Premature, Diseases

Interventions

Digoxin

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Christoph Hornik, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Hammett, BS/BA

CONTACT

919-668-8432; Alex.Hammett@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will receive population specific PK model-derived digoxin dosing.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)