MedTrace Logo

PK/PD of Digoxin in Infants With SVHD

NCT06613477 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-30

No results posted yet for this study

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

Interventions

DRUG

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

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

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Duke Clinical Research Institute

    collaborator OTHER

  • National Center for Child Health and Development (NICHD)

    collaborator UNKNOWN

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

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Christoph Hornik, MD · Duke Clinical Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Days
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06613477 on ClinicalTrials.gov