Understanding how digoxin affects infants with single ventricle heart disease

Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease

This study is testing how digoxin affects infants with single ventricle heart disease to see how their bodies process the medication and how it helps their heart function.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 30 Days to 6 Months
• Sex: All
• Sponsor: Duke University (other)
• Locations: 2 sites (Durham, North Carolina and 1 other locations)
• Trial ID: NCT06613477 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics and pharmacodynamics of digoxin in infants diagnosed with single ventricle heart disease. It involves a multi-center, prospective, open-label design where blood samples will be collected opportunistically during routine care to assess how digoxin is processed in the body and its effects on cardiac function. Participants will receive digoxin dosing based on a population-specific model, and the study will last up to 180 days. The data collected will help refine treatment approaches for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are infants aged 30 days or younger who have undergone stage 1 palliation for single ventricle congenital heart disease and require treatment with digoxin.

Not a fit: Patients who are premature at birth, have significant renal impairment, or have contraindications to digoxin will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dosing strategies for digoxin in infants with single ventricle heart disease, enhancing their cardiac function and overall health outcomes.

How similar studies have performed: While studies on digoxin in pediatric populations exist, this specific approach focusing on single ventricle heart disease in infants is relatively novel and has not been extensively tested.

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 enteral digoxin per their treating medical provider
6. Informed consent obtained from parent(s) or legal guardian(s)

Exclusion Criteria:

1. Gestational age at birth \<35 weeks
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
8. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study

Where this trial is running

Durham, North Carolina and 1 other locations

• Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Christoph Hornik, MD — Duke Clinical Research Institute
• Study coordinator: Alex Hammett, BS/BA

Conditions: Single-ventricle, Infant Conditions, Infant, Newborn, Diseases, Infant, Premature, Diseases, Infants, SVD, SVHD, Single Ventricle