PK/PD of Digoxin in Infants With SVHD

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06613477
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Infant Conditions
  • Infant, Newborn, Diseases
  • Infant, Premature, Diseases
  • Single-ventricle

Eligibility Criteria

Sex
ALL
Age
30 Days - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease — DRUG
    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

Study Details

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.

Key Dates

Start date
Oct 10, 2024
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Population specific PK model-derived digoxin dosing
    Digoxin elixir will be used to dose enterally every 12 hours. The dosage will be determined by the protocol PK model. Dosing is to be administered based on weight, postnatal age, and estimated glomerular filtration rate The duration of the participation could be up to 180 days. Day 1 to S2P or Day 180 (+/- 7)

Primary Outcome Measure

Digoxin plasma concentration [ Time Frame: End of study, up to 180 Days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27701
Elizabeth Thompson, MD
[email protected]
Medical University of South CarolinaCharlestonSouth Carolina29425
Eric Graham, MD
[email protected]

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