Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Recruiting Phase 1 study of Single-ventricle and Infant, Newborn, Diseases, sponsored by Duke University.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Plasma concentrations of digoxin over time measured using a validated bioanalytical assay at a central laboratory to calculate clearance and area under the curve (AUC)

Conditions Studied

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

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

FieldValue
Enrollment Target 20 participants
Start Date 2024-10-10
Est. Completion 2026-11-30
Phase Phase 1
Duke University

1,725 total trials

What NCT06613477 shows while recruiting

NCT06613477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 85-participant average among 17 other Single-ventricle trials with a reported enrollment target (76% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Single-ventricle

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06613477's enrollment target sits among peer trials

20 13th of 17 higher than 3 of 17 other Single-ventricle trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Single-ventricle trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00573339 · 20 participants

    Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing

  • NCT00692939 · 20 participants · Phase 1

    Autologous Stem Cell Transplantation for Crohn's Disease

  • NCT00967785 · 20 participants · Phase 1

    A Phase I Study of Mozobil in the Treatment of Patients With WHIMS

  • NCT01406691 · 20 participants · Phase 4

    Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06613477

Source: ClinicalTrials.gov NCT06613477, the US trial registry maintained by the National Library of Medicine. NCT06613477 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.