Actively Recruiting
PK/PD of Digoxin in Infants With SVHD
Led by Duke University · Updated on 2026-01-30
20
Participants Needed
2
Research Sites
111 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
M
Medical University of South Carolina
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
PK/PD of Digoxin in Infants With SVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of single ventricle congenital heart disease
- Completed stage 1 surgical or hybrid palliation but not yet stage 2 palliation
- Age 30 days or less at time of stage 1 palliation
- Younger than 6 months at enrollment
- Require enteral digoxin treatment as determined by medical provider
- Informed consent obtained from parent(s) or legal guardian(s)
You will not qualify if you...
- Born before 35 weeks of gestation
- Serum creatinine greater than 2 mg/dL at enrollment
- Second degree or higher atrioventricular conduction block at enrollment
- Clinically significant sinus bradycardia requiring intervention at enrollment
- Known allergy to digoxin or digitalis
- Receiving extracorporeal life support (ECMO, dialysis, ventricular assist device) at enrollment
- Received digoxin before enrolling
- Any condition making participation unsuitable per investigator's opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Duke University Medical Center
Durham, North Carolina, United States, 27701
Actively Recruiting
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
Research Team
A
Alex Hammett, BS/BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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