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Researchers study digoxin dosing in infants with rare heart condition

NCT ID NCT06613477

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study looks at how the heart medication digoxin is processed in infants born with single ventricle heart disease. Researchers will collect blood samples during routine care to measure drug levels. The goal is to better understand dosing, but the study does not change the infant's treatment plan. About 20 infants under 6 months old will participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
digoxin (Lanoxin)
What this could lead to
If successful, this could lead to more precise digoxin dosing for infants with single ventricle heart disease, potentially improving heart function and reducing side effects.
What could go wrong
This is an early-phase study with only 20 infants, so results may not apply to all patients. The study does not test whether digoxin improves outcomes, only how it is processed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

24 people

The number who actually took part.

Started

Oct 2024

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 days to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Infant, Newborn, Diseases Infant, Premature, Diseases perinatal disease univentricular cardiopathy univentricular heart

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infant conditions Infant, newborn, diseases Infant, premature, diseases Single-ventricle

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27701, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

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