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Cardiac Glycoside

Digoxin for Single Ventricle Heart

Phase 1 & 2
Waitlist Available
Led By Christoph Hornik, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age < 6 months at time of enrollment
Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
Must not have
Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
Received digoxin prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, up to 180 days
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to understand how the medication digoxin affects infants with single ventricle heart disease. Researchers will collect blood samples during regular check-ups and review medical records. Participating in the study

Who is the study for?
This clinical trial is for infants with a heart condition known as single ventricle heart disease. To participate, they must already be receiving routine care in a pediatric cardiac intensive care unit.
What is being tested?
The study is examining how the drug Digoxin, commonly given to infants with heart disease, is processed by their bodies and its effects on their heart function. Blood samples will be taken during regular care to analyze this.
What are the potential side effects?
Potential side effects include risks associated with blood draws such as discomfort or bruising at the site of needle insertion and loss of confidentiality regarding medical information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 6 months old.
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I've had the first stage of heart surgery but not the second.
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My child is 30 days old or younger and needs the first stage of a heart operation.
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I have been diagnosed with single ventricle heart condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a slow heartbeat that needs treatment.
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I have taken digoxin before joining this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, up to 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, up to 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Digoxin plasma concentration

Side effects data

From 2018 Phase 4 trial • 178 Patients • NCT03136068
2%
hemmorhage
1%
pregnancy labor
1%
fever
1%
cramping
1%
severe nausea
1%
vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Digoxin
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Population specific PK model-derived digoxin dosingExperimental Treatment1 Intervention
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)

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,446 Previous Clinical Trials
3,067,809 Total Patients Enrolled
National Center for Child Health and Development (NICHD)UNKNOWN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,040 Previous Clinical Trials
2,671,452 Total Patients Enrolled
~13 spots leftby Dec 2025
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