PK/PD of Digoxin in Infants With SVHD
Recruiting
Phase 1
Phase 2
Interventional Study
Single-ventricle
Infant Conditions
Infant, Newborn, Diseases
Infant, Premature, Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 30 Days – 6 Months
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Duke University · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 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 enter…
Contacts