NCT06613477 · Duke University
PK/PD of Digoxin in Infants With SVHD
What this study is about
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.
View original scientific description
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").
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
Primary outcome measures
Digoxin plasma concentration
Time frame: End of study, up to 180 Days
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of single ventricle congenital heart disease 2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation 3. Age ≤ 30 days of life at time of stage 1 palliation 4. Age \< 6 months at time of enrollment 5. Require treatment with enteral digoxin per their treating medical provider 6. Informed consent obtained from parent(s) or legal guardian(s)
Exclusion criteria
- Prematurity (gestational age \<37 weeks) at birth 2. Serum creatinine \> 2 mg/dL at enrollment 3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment 4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment 5. Known hypersensitivity to digoxin or other forms of digitalis 6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment 7. Received digoxin prior to enrollment
Where
- Durham, North Carolina
- Charleston, South Carolina
Collaborators
Medical University of South Carolina, Duke Clinical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations