PK/PD of Digoxin in Infants With SVHD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age30-6
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
DrugTable 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Population specific PK model-derived digoxin dosingExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
End of study, up to 180 DaysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Medical University of South Carolina
Collaborator
Duke Clinical Research Institute
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov