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| ID | Type | Description | Link |
|---|---|---|---|
| NICHD-2018-DGX01 | Other Identifier | Duke | |
| HHSN27500002 | Other Grant/Funding Number | NICHD |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with single ventricle congenital heart disease | Receiving digoxin per standard of care during the interstage period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of digoxin | The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory. | Approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events related to study procedures and serious, unexpected, suspected adverse reactions related to digoxin | 1. 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. | Approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of NT-proBNP | Approximately 7 months | |
| Plasma concentration of MR-proANP | Approximately 7 months | |
| Right ventricular or left ventricular end diastolic volume |
Inclusion Criteria:
Exclusion Criteria:
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Up to 48 infants diagnosed with single ventricle congenital heart disease, receiving digoxin per standard of care during the interstage period
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Hornik, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mattel Children's Hospital at UCLA | Los Angeles | California | 90095 | United States | ||
| Rady Childrens Hospital and Health Center |
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Blood samples will be collected to assess pharmacokinetic and biomarker levels
| Tachyarrthmias | Event of special interest will be captured (number of tachyarrythmias) | Approximately 7 months |
| Number of participants with second and third degree atrioventricular conduction block | Approximately 7 months |
| Number of participants with sinus bradycardia | Number of participants with sinus bradycardia | Approximately 7 months |
| Number of participants with need for temporary or permanent pacing | Number of participants with need for temporary or permanent pacing | Approximately 7 months |
| Frequency of death | Frequency of death | Approximately 7 months |
| PR interval | Derived from electrocardiograms and their reports performed per standard of care | Approximately 7 months |
| QRS duration | Derived from electrocardiograms and their reports performed per standard of care | Approximately 7 months |
| QT interval | Derived from electrocardiograms and their reports performed per standard of care | Approximately 7 months |
| Corrected QT interval using Bazett's formula | Derived from electrocardiograms and their reports performed per standard of care | Approximately 7 months |
| Approximately 7 months |
| Right ventricular or left ventricular end systolic volume | Approximately 7 months |
| Right ventricular or left ventricular ejection fraction | Approximately 7 months |
| Right ventricular or left ventricular shortening fraction | Approximately 7 months |
| Right ventricular or left ventricular end diastolic dimension | Approximately 7 months |
| Right ventricular or left ventricular end systolic dimension | Approximately 7 months |
| Right ventricular or left ventricular fractional area change | Approximately 7 months |
| Degree of atrioventricular valve regurgitation | Approximately 7 months |
| Qualitative right ventricular or left ventricular function assessment | Approximately 7 months |
| Cardiac output | As measured by cardiac catheterization | Approximately 7 months |
| Pulmonary to systemic blood flow ratio | As measured by cardiac catheterization | Approximately 7 months |
| Pulmonary vascular resistance | As measured by cardiac catheterization | Approximately 7 months |
| Mean pulmonary artery pressure | As measured by cardiac catheterization | Approximately 7 months |
| Right ventricular or left ventricular end diastolic pressure | As measured by cardiac catheterization | Approximately 7 months |
| Right ventricular or left ventricular end systolic pressure | As measured by cardiac catheterization | Approximately 7 months |
| Right and left pulmonary artery size | As measured by cardiac catheterization | Approximately 7 months |
| Pressure gradients across the aortic arch | As measured by cardiac catheterization | Approximately 7 months |
| Incidence of unplanned surgical intervention | Including cannulation for mechanical circulatory support | Approximately 7 months |
| Incidence of listing for heart transplant | Approximately 7 months |
| Incidence of receiving heart transplant | Approximately 7 months |
| Hospital length of stay after S1P | Approximately 7 months |
| Number of days on mechanical ventilation after S1P | Approximately 7 months |
| Number of hospital readmissions from S1P discharge to S2p | Approximately 7 months |
| San Diego |
| California |
| 92123 |
| United States |
| The Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Alfred I. DuPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Morgan Stanley Children's Hospital of New York Presbyterian | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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