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NCT06613477 · ClinicalTrials.gov registry record · Phase 1
PK/PD of Digoxin in Infants With SVHD
A Phase 1 study of Single-ventricle and Infant, Newborn, Diseases, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06613477 is a Phase 1 study of Single-ventricle and Infant, Newborn, Diseases that is actively recruiting participants, run by Duke University. The registered enrollment target is 20 participants, below the 85-participant average among 17 other Single-ventricle trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06613477, a Phase 1 study of Single-ventricle and Infant, Newborn, Diseases, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
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 Studied
Interventions
- DRUG PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
Study Locations (2)
North Carolina
- Duke University Medical Center - Durham
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-10-10 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06613477
The ClinicalTrials.gov registry entry for NCT06613477 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 17 other Single-ventricle trials with a reported enrollment target (76% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Single-ventricle appearing as the primary indexed condition, and to 1 intervention - of which PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease is the first listed.
NCT06613477 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, South Carolina.
Frequently Asked Questions
What is clinical trial NCT06613477 about?
NCT06613477 is a clinical study titled "PK/PD of Digoxin in Infants With SVHD". 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...
What is the current status of trial NCT06613477?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-10-10. Estimated completion is 2026-11-30.
What conditions does trial NCT06613477 study?
This clinical trial studies the following conditions: Single-ventricle, Infant, Newborn, Diseases, Infant, Premature, Diseases, Infant Conditions.
What interventions are being tested in trial NCT06613477?
The interventions under investigation include: PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease (DRUG).
Who is sponsoring clinical trial NCT06613477?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06613477 being conducted?
This trial has 2 study locations across North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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