Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease (DGX01)
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ClinicalTrials.gov Identifier: NCT03877965 |
Recruitment Status :
Enrolling by invitation
First Posted : March 18, 2019
Last Update Posted : October 1, 2020
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Condition or disease | Intervention/treatment |
---|---|
Congenital Heart Disease | Drug: Digoxin |
Study Type : | Observational |
Estimated Enrollment : | 48 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease |
Actual Study Start Date : | August 5, 2019 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | December 1, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
Children with single ventricle congenital heart disease
Receiving digoxin per standard of care during the interstage period
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Drug: Digoxin
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 |
- Plasma concentrations of digoxin [ Time Frame: Approximately 7 months ]
- Number of adverse events related to study procedures and serious, unexpected, suspected adverse reactions related to digoxin [ Time Frame: Approximately 7 months ]
- Number of participants with tachyarrhythmias [ 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 ]Derived from electrocardiograms and their reports performed per standard of care
- QRS duration [ Time Frame: Approximately 7 months ]Derived from electrocardiograms and their reports performed per standard of care
- QT interval [ Time Frame: Approximately 7 months ]Derived from electrocardiograms and their reports performed per standard of care
- Corrected QT interval using Bazett's formula [ Time Frame: Approximately 7 months ]Derived from electrocardiograms and their reports performed per standard of care
- Plasma concentration of NT-proBNP [ Time Frame: Approximately 7 months ]
- Plasma concentration of MR-proANP [ Time Frame: Approximately 7 months ]
- Right ventricular or left ventricular end diastolic volume [ Time Frame: Approximately 7 months ]
- Right ventricular or left ventricular end systolic volume [ Time Frame: Approximately 7 months ]
- Right ventricular or left ventricular ejection fraction [ Time Frame: Approximately 7 months ]
- Right ventricular or left ventricular shortening fraction [ Time Frame: Approximately 7 months ]
- Right ventricular or left ventricular end diastolic dimension [ Time Frame: Approximately 7 months ]
- Right ventricular or left ventricular end systolic dimension [ Time Frame: Approximately 7 months ]
- Right ventricular or left ventricular fractional area change [ Time Frame: Approximately 7 months ]
- Degree of atrioventricular valve regurgitation [ Time Frame: Approximately 7 months ]
- Qualitative right ventricular or left ventricular function assessment [ Time Frame: Approximately 7 months ]
- Cardiac output [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Pulmonary to systemic blood flow ratio [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Pulmonary vascular resistance [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Mean pulmonary artery pressure [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Right ventricular or left ventricular end diastolic pressure [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Right ventricular or left ventricular end systolic pressure [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Right and left pulmonary artery size [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Pressure gradients across the aortic arch [ Time Frame: Approximately 7 months ]As measured by cardiac catheterization
- Incidence of unplanned surgical intervention [ Time Frame: Approximately 7 months ]Including cannulation for mechanical circulatory support
- Incidence of listing for heart transplant [ Time Frame: Approximately 7 months ]
- Incidence of receiving heart transplant [ Time Frame: Approximately 7 months ]
- Hospital length of stay after S1P [ Time Frame: Approximately 7 months ]
- Number of days on mechanical ventilation after S1P [ Time Frame: Approximately 7 months ]
- Number of hospital readmissions from S1P discharge to S2p [ Time Frame: Approximately 7 months ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | up to 6 Months (Child) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877965
United States, California | |
Mattel Children's Hospital at UCLA | |
Los Angeles, California, United States, 90095 | |
Rady Childrens Hospital and Health Center | |
San Diego, California, United States, 92123 | |
United States, Colorado | |
The Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Delaware | |
Alfred I. DuPont Hospital for Children | |
Wilmington, Delaware, United States, 19803 | |
United States, Florida | |
Nicklaus Children's Hospital | |
Miami, Florida, United States, 33155 | |
United States, Missouri | |
St. Louis Children's Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Morgan Stanley Children's Hospital of New York Presbyterian | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cincinnati Childrens Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
Children's Memorial Hermann Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Christoph Hornik, MD | Duke University |
Responsible Party: | Christoph P Hornik, MD MPH, Associate Professor of Pediatrics, Duke University |
ClinicalTrials.gov Identifier: | NCT03877965 |
Other Study ID Numbers: |
Pro00102130 NICHD-2018-DGX01 ( Other Identifier: Duke ) HHSN27500002 ( Other Grant/Funding Number: NICHD ) |
First Posted: | March 18, 2019 Key Record Dates |
Last Update Posted: | October 1, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities Digoxin |
Anti-Arrhythmia Agents Cardiotonic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |