PK/PD of Digoxin in Infants With SVHD

Description

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.

Conditions

Single-ventricle, Infant Conditions, Infant, Newborn, Diseases, Infant, Premature, Diseases

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Study Overview

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Study Details

Study overview

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.

Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease

PK/PD of Digoxin in Infants With SVHD

Condition
Single-ventricle
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27701

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 1. Prematurity (gestational age \<37 weeks) at birth
  • 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

Ages Eligible for Study

30 Days to 6 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Christoph Hornik, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

2025-12-31