20 Participants Needed

Digoxin for Single Ventricle Heart

Recruiting at 1 trial location
AH
Overseen ByAlex Hammett, BS/BA
Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Duke University
Must be taking: Digoxin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The study will not change your treatment plan or medications, so you can continue taking your current medications.

What data supports the effectiveness of the drug Digoxin for heart conditions?

Research shows that Digoxin can improve symptoms and exercise capacity in patients with heart failure due to systolic dysfunction, and it is beneficial for controlling heart rate in patients with atrial fibrillation. However, its effect on mortality is unclear, and it should be used with caution.12345

Is digoxin generally safe for human use?

Digoxin has been used for over 200 years and is generally considered safe, but it can cause heart rhythm problems and other side effects, especially in the elderly or when used with certain other medications. It has a narrow margin between effective and toxic doses, so careful monitoring is important.14567

How is the drug digoxin unique in treating single ventricle heart conditions?

Digoxin is unique because it has been used for over 200 years to treat heart conditions by improving heart function and reducing hospital admissions for heart failure. It is the only oral inotropic agent (a drug that increases the strength of heart muscle contractions) currently used in clinical practice for heart failure, making it distinct from other treatments.13678

What is the purpose of this trial?

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.

Research Team

CH

Christoph Hornik, MD

Principal Investigator

Duke Clinical Research Institute

Eligibility Criteria

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.

Inclusion Criteria

I am under 6 months old.
I've had the first stage of heart surgery but not the second.
My child is 30 days old or younger and needs the first stage of a heart operation.
See 3 more

Exclusion Criteria

Prematurity (gestational age <37 weeks) at birth
Serum creatinine > 2 mg/dL at enrollment
I have a slow heartbeat that needs treatment.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive population-specific PK model-derived digoxin dosing

Up to 180 days
Regular visits for PK and PD sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Digoxin
Trial Overview 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.
Participant Groups
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)

Digoxin is already approved in European Union, United States, Canada, Japan for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Lanoxin for:
  • Atrial fibrillation
  • Atrial flutter
  • Supraventricular tachycardia
  • Congestive heart failure
πŸ‡ΊπŸ‡Έ
Approved in United States as Lanoxin for:
  • Atrial fibrillation
  • Atrial flutter
  • Supraventricular tachycardia
  • Congestive heart failure
πŸ‡¨πŸ‡¦
Approved in Canada as Lanoxin for:
  • Atrial fibrillation
  • Atrial flutter
  • Supraventricular tachycardia
  • Congestive heart failure
πŸ‡―πŸ‡΅
Approved in Japan as Lanoxin for:
  • Atrial fibrillation
  • Atrial flutter
  • Supraventricular tachycardia
  • Congestive heart failure

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Center for Child Health and Development (NICHD)

Collaborator

Trials
1
Recruited
20+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

Duke Clinical Research Institute

Collaborator

Trials
69
Recruited
242,000+

Findings from Research

Digitalis, particularly through intravenous administration, can significantly improve heart function in patients with chronic heart failure, increasing cardiac index and reducing heart rate, with these benefits lasting into long-term oral therapy.
Adding digoxin to standard treatments like vasodilators and diuretics provides additional clinical benefits for patients with moderate to severe heart failure symptoms due to systolic ventricular dysfunction.
A reexamination of the hemodynamic effects of digitalis relative to ventricular dysfunction.Vitarelli, A., Fedele, F., Dagianti, A., et al.[2018]
Digoxin remains effective for treating patients with congestive heart failure (CHF) who also have atrial fibrillation, but it does not reduce mortality rates, as shown in large randomized trials.
The use of digoxin should be personalized, as it may benefit some patients with CHF due to systolic dysfunction but is not effective for those with diastolic dysfunction or certain congenital heart conditions.
Does digoxin still have a role in congestive heart failure?Kothari, SS.[2019]
Recent double-blind, randomized trials show that digoxin improves left ventricular ejection fraction, increases exercise capacity, and prevents worsening of congestive heart failure (CHF) compared to placebo, indicating its efficacy in treatment.
While digoxin provides benefits similar to ACE inhibitors in improving heart function, it does not improve survival rates, and its effects on mortality in CHF patients are still being studied in ongoing trials.
Review of randomized trials of digoxin therapy in patients with chronic heart failure.Gheorghiade, M., Zarowitz, BJ.[2019]

References

A reexamination of the hemodynamic effects of digitalis relative to ventricular dysfunction. [2018]
Does digoxin still have a role in congestive heart failure? [2019]
Review of randomized trials of digoxin therapy in patients with chronic heart failure. [2019]
Heart failure: to digitalise or not? The view against. [2019]
The effect of digoxin on the quality of life in patients with heart failure. [2015]
The safety of digoxin as a pharmacological treatment of atrial fibrillation. [2019]
When, and when not, to use digoxin in the elderly. [2018]
Is foxglove effective in heart failure? [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security