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New treatment option for Single-ventricle
Official title PK/PD of Digoxin in Infants With SVHD
ClinicalTrials.gov ID: NCT06613477
What this study is testing
What is PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease?
PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease is an investigational medicine, given as an once-daily, being studied as a potential treatment for single-ventricle.
Also referred to as Lanoxin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 6
You may be able to join if
- Diagnosis of single ventricle congenital heart disease
- Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
- Age ≤ 30 days of life at time of stage 1 palliation
- Age \< 6 months at time of enrollment
- Require treatment with enteral digoxin per their treating medical provider
You likely can't join if
- Gestational age at birth \<35 weeks
- Serum creatinine \> 2 mg/dL at enrollment
- Diagnosis of second degree or higher atrioventricular conduction block at enrollment
- Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
- Known hypersensitivity to digoxin or other forms of digitalis
- Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
See the full eligibility criteria
- Diagnosis of single ventricle congenital heart disease
- Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
- Age ≤ 30 days of life at time of stage 1 palliation
- Age \< 6 months at time of enrollment
- Require treatment with enteral digoxin per their treating medical provider
- Informed consent obtained from parent(s) or legal guardian(s)
- Gestational age at birth \<35 weeks
- Serum creatinine \> 2 mg/dL at enrollment
- Diagnosis of second degree or higher atrioventricular conduction block at enrollment
- Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
- Known hypersensitivity to digoxin or other forms of digitalis
- Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
- Received digoxin prior to enrollment
- Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 days to 6 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.