Digoxin for Single Ventricle Heart
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive population-specific PK model-derived digoxin dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Digoxin
Digoxin is already approved in European Union, United States, Canada, Japan for the following indications:
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
- Atrial fibrillation
- Atrial flutter
- Supraventricular tachycardia
- Congestive heart failure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Center for Child Health and Development (NICHD)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Medical University of South Carolina
Collaborator
Duke Clinical Research Institute
Collaborator