Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Plasma concentrations of digoxin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Children with single ventricle congenital heart disease
Receiving digoxin per standard of care during the interstage period
干预措施: Digoxin (Drug)
结局指标
主要结局
Plasma concentrations of digoxin
时间窗: Approximately 7 months
The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory.
次要结局
- Number of participants with second and third degree atrioventricular conduction block(Approximately 7 months)
- PR interval(Approximately 7 months)
- Number of adverse events related to study procedures and serious, unexpected, suspected adverse reactions related to digoxin(Approximately 7 months)
- Number of participants with sinus bradycardia(Approximately 7 months)
- Tachyarrthmias(Approximately 7 months)
- Number of participants with need for temporary or permanent pacing(Approximately 7 months)
- Frequency of death(Approximately 7 months)
- QT interval(Approximately 7 months)
- Corrected QT interval using Bazett's formula(Approximately 7 months)
- QRS duration(Approximately 7 months)
研究者
Christoph P Hornik, MD MPH
Associate Professor of Pediatrics
Duke University