Congenital Heart DiseaseDGX01NCT03877965
Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Christoph P Hornik, MD MPH at 11 sites in United States.
Trial summary
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Digoxin
- How many people
- 50 participants
- Where
- 11 sitesUnited States
- Study dates
- 5 Aug 2019to 17 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Child
Study population: Up to 48 infants diagnosed with single ventricle congenital heart disease, receiving digoxin per standard of care during the interstage period
Who may be able to join
- Diagnosis of single ventricle congenital heart disease
- Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
- Age ≤ 30 days of life at time of stage 1 palliation
- Age < 6 months at time of enrollment
- Require treatment with enteral digoxin per their treating medical provider if their planned maintenance treatment dosing regimen is within the labeled dose range of 7.5 - 20 mcg/kg/day divided in 2 or 3 equal doses
- Informed consent from parent(s) or legal guardian(s)
Who cannot join
- Serum creatinine > 2 mg/dL at enrollment
- Diagnosis of second degree or higher atrioventricular conduction block at enrollment
- Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
- Known hypersensitivity to digoxin or other forms of digitalis
- Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
- Received digoxin prior to enrollment
- Received or anticipated to receive a loading dose of digoxin.
- Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
The Children's Hospital Colorado
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Duke University Medical Center
Durham, North Carolina, 27710
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Mattel Children's Hospital at UCLA
Los Angeles, California, 90095
Nicklaus Children's Hospital
Miami, Florida, 33155
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, 10032
Rady Childrens Hospital and Health Center
San Diego, California, 92123
St. Louis Children's Hospital
St Louis, Missouri, 63110
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803
About this study
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.
Read the detailed description
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded this protocol titled "Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease", protocol number NICHD-2018-DGX01. The Investigational New Drug (IND) Sponsor and Principal Investigator for this protocol is Christopher P. Hornik, MD, MPH. The Contracting Officer's Technical Representative (COTR) to represent the Government for this task order is Perdita Taylor-Zapata. The Duke IRB number for this study is Pro00102130. This study employs a central IRB, the WIRB-Copernicus Group (WCG). The c-IRB (WCG) study number is 20190888 / NICHD-2018-DGX01.
This is a prospective, multicenter Phase 1 study with a primary objective to characterize the pharmacokinetics of enteral digoxin in infants with single ventricle congenital heart disease. The secondary objective is to determine the safety profile of enteral digoxin in infants with single ventricle congenital heart disease. Digoxin is used for the treatment of heart failure in pediatric patients and acts by controlling numerous functions of the cardiovascular system. Digoxin use in single ventricle congenital heart disease may decrease interstage mortality.
The study will be conducted in approximately 48 subjects at approximately 13 investigational centers. The proposed duration of the study is approximately 196 (±) days.
Please see the protocol and synopsis for more information.
- Conditions
- Congenital Heart Disease
- Being tested
- Digoxin
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigoxinDrug
Drug administered per standard of care, with a dosing regimen within the labeled dose range of 7.5-20 mcg/kg/day divided in 2 or 3 equal doses
| Study group | Role | What they receive |
|---|---|---|
| Children with single ventricle congenital heart disease | Receiving digoxin per standard of care during the interstage period Receives: Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of digoxin
The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory.
Measured: Approximately 7 months
Secondary outcomes (10)
Number of adverse events related to study procedures and serious, unexpected, suspected adverse reactions related to digoxin
- Adverse events (AEs) related to the study procedures (blood draws and outcome assessments), and serious, unexpected, suspected adverse reactions (SUSARs) related to digoxin will be captured.
Measured: Approximately 7 months
Tachyarrthmias
Event of special interest will be captured (number of tachyarrythmias)
Measured: Approximately 7 months
Number of participants with second and third degree atrioventricular conduction block
Measured: Approximately 7 months
Number of participants with sinus bradycardia
Number of participants with sinus bradycardia
Measured: Approximately 7 months
Number of participants with need for temporary or permanent pacing
Number of participants with need for temporary or permanent pacing
Measured: Approximately 7 months
Frequency of death
Frequency of death
Measured: Approximately 7 months
PR interval
Derived from electrocardiograms and their reports performed per standard of care
Measured: Approximately 7 months
QRS duration
Derived from electrocardiograms and their reports performed per standard of care
Measured: Approximately 7 months
QT interval
Derived from electrocardiograms and their reports performed per standard of care
Measured: Approximately 7 months
Corrected QT interval using Bazett's formula
Derived from electrocardiograms and their reports performed per standard of care
Measured: Approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start5 Aug 2019
- Primary completion13 Jul 2021
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph P Hornik, MD MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, Christoph P Hornik, MD MPH, Duke University
- Investigators
- Christoph Hornik, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877965
- Sponsor's protocol ID
- Pro00102130
- Other IDs
- NICHD-2018-DGX01, HHSN27500002
- Acronym
- DGX01
- Status last verified
- Oct 2022
- First submitted
- 14 Mar 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03877965
- Acronym / sponsor ID
- DGX01 / Pro00102130
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Christoph P Hornik, MD MPHUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.
Detailed description
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded this protocol titled "Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease", protocol number NICHD-2018-DGX01. The Investigational New Drug (IND) Sponsor and Principal Investigator for this protocol is Christopher P. Hornik, MD, MPH. The Contracting Officer's Technical Representative (COTR) to represent the Government for this task order is Perdita Taylor-Zapata. The Duke IRB number for this study is Pro00102130. This study employs a central IRB, the WIRB-Copernicus Group (WCG). The c-IRB (WCG) study number is 20190888 / NICHD-2018-DGX01.
This is a prospective, multicenter Phase 1 study with a primary objective to characterize the pharmacokinetics of enteral digoxin in infants with single ventricle congenital heart disease. The secondary objective is to determine the safety profile of enteral digoxin in infants with single ventricle congenital heart disease. Digoxin is used for the treatment of heart failure in pediatric patients and acts by controlling numerous functions of the cardiovascular system. Digoxin use in single ventricle congenital heart disease may decrease interstage mortality.
The study will be conducted in approximately 48 subjects at approximately 13 investigational centers. The proposed duration of the study is approximately 196 (±) days.
Please see the protocol and synopsis for more information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with single ventricle congenital heart disease | – | Drug: DigoxinReceiving digoxin per standard of care during the interstage period |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Age groups
- Child
- Study population
- Up to 48 infants diagnosed with single ventricle congenital heart disease, receiving digoxin per standard of care during the interstage period
Key inclusion criteria (6 listed)
- Diagnosis of single ventricle congenital heart disease
- Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation
- Age ≤ 30 days of life at time of stage 1 palliation
- Age < 6 months at time of enrollment
- Require treatment with enteral digoxin per their treating medical provider if their planned maintenance treatment dosing regimen is within the labeled dose range of 7.5 - 20 mcg/kg/day divided in 2 or 3 equal doses
Key exclusion criteria (8 listed)
- Serum creatinine > 2 mg/dL at enrollment
- Diagnosis of second degree or higher atrioventricular conduction block at enrollment
- Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment
- Known hypersensitivity to digoxin or other forms of digitalis
- Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DigoxinDrug administered per standard of care, with a dosing regimen within the labeled dose range of 7.5-20 mcg/kg/day divided in 2 or 3 equal doses | Drug | Children with single ventricle congenital heart disease |
Primary outcome
Plasma concentrations of digoxin
Time frame: Approximately 7 months
The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory.
10 secondary outcomes
Number of adverse events related to study procedures and serious, unexpected, suspected adverse reactions related to digoxin
Time frame: Approximately 7 months
Tachyarrthmias
Time frame: Approximately 7 months
Number of participants with second and third degree atrioventricular conduction block
Time frame: Approximately 7 months
Number of participants with sinus bradycardia
Time frame: Approximately 7 months
Number of participants with need for temporary or permanent pacing
Time frame: Approximately 7 months
Frequency of death
Time frame: Approximately 7 months
PR interval
Time frame: Approximately 7 months
QRS duration
Time frame: Approximately 7 months
QT interval
Time frame: Approximately 7 months
Corrected QT interval using Bazett's formula
Time frame: Approximately 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hornik, MD principal investigator
Duke University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Christoph P Hornik, MD MPH at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of digoxin (time frame: Approximately 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.