RECRUITING

PK/PD of Digoxin in Infants With SVHD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-10
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06613477

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.

Ages Eligible for Study:30 Days to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of single ventricle congenital heart disease
  2. 2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
  3. 3. Age ≤ 30 days of life at time of stage 1 palliation
  4. 4. Age \< 6 months at time of enrollment
  5. 5. Require treatment with enteral digoxin per their treating medical provider
  6. 6. Informed consent obtained from parent(s) or legal guardian(s)
  1. 1. Prematurity (gestational age \<37 weeks) at birth
  2. 2. Serum creatinine \> 2 mg/dL at enrollment
  3. 3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment
  4. 4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
  5. 5. Known hypersensitivity to digoxin or other forms of digitalis
  6. 6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
  7. 7. Received digoxin prior to enrollment

Contacts and Locations

Study Contact

Alex Hammett, BS/BA
CONTACT
919-668-8432
Alex.Hammett@duke.edu

Principal Investigator

Christoph Hornik, MD
PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27701
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Duke University

  • Christoph Hornik, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-10-10
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Infants
  • SVD
  • SVHD
  • Single Ventricle
  • Digoxin
  • Pharmacokinetics
  • Pharmacodynamics
  • PK
  • PD

Additional Relevant MeSH Terms

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