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Cardiac Glycoside

Digoxin for Single Ventricle Heart

Phase 1 & 2

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study, up to 180 days

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

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)

0 / 6Eligibility criteria met