Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 14
- 主要终点
- Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.
研究概览
简要总结
This is a randomized, double-blind, multi-centered study to compare 6 months of medical treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for pediatric use in a controlled trial in the context of SVT, yet both medications are used frequently.
Specific aims of the study:
To determine whether propranolol and digoxin differ in the:
- Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or digoxin
- Time to first recurrence of SVT in infants treated with propranolol or digoxin.
- Incidence of adverse outcomes in infants treated with propranolol or digoxin.
详细描述
The purpose of the proposed research is to conduct a randomized double-blind, multi-centre study of two antiarrhythmic medications, digoxin and propranolol, to evaluate whether one of these medications is more effective in reducing risk of recurrent supraventricular tachycardia (SVT) in infants.
SVT is the most common sustained arrhythmia of infancy, occurring in 1 in 250-1000 children, and is a serious health burden in Canada and internationally [1, 5-8]. SVT is a common clinical problem facing many health care providers, including general pediatricians, emergency room physicians, nurses, cardiologists, and intensive care physicians. SVT carries significant morbidity and mortality, and patients typically receive long-term medical therapy. Untreated, an infant can tolerate SVT for only a short period before heart failure and shock (or even death) ensues. The management of SVT is currently under debate and often appears to depend on physician preference [9]. While spontaneous termination of the acute episode may occur [1, 2, 6, 9, 10], many infants require medical intervention to terminate the episode. Vagal maneuvres and adenosine have reasonable success in terminating an acute SVT episode, but other medications may also be required. Once the acute episode is treated, the physician(s) must make a decision whether or not to start maintenance (chronic) therapy.
At present, there is no clinical consensus for the management of SVT in infancy. The rationale for chronic therapy in SVT is to prevent recurrences and to limit symptoms during recurrences. Yet SVT recurrences are not readily predictable [11]. Many medications are available to treat SVT; however, these medications have associated risks and there are psychosocial implications for families. To date, most medications used to treat infant SVT have not been evaluated in controlled studies of infants. Thus, at present, physicians must make decisions about initiation and duration of chronic therapy and choice of medication in the absence of evidence from controlled clinical trials. A prospective, randomized clinical study is crucial to provide evidence to guide therapy of infant SVT.
As a preliminary study to inform the proposed trial, we carried out a survey of all pediatric cardiologists in North America [12]. In this survey, we presented hypothetical cases of infants with SVT and asked about acute and chronic management. Several points are clear:
- 11 different medications were chosen for the management of infant SVT;
- there was a discrepancy among respondents with respect to medication choices, based on whether the respondent had additional electrophysiology training or not; and
- several physicians selected digoxin in infants who have Wolff-Parkinson-White syndrome ; this medication choice may have deleterious effects in these infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 4 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation with SVT due to AVRT or AVNRT.
- •Age 4 months or less at presentation.
- •No major structural heart disease (patent foramen ovale and patent ductus arteriosus are allowable.
- •No other significant co-morbid condition likely to result in non-compliance or death in next 6 months.
- •The SVT mechanism will be presumed to be AVRT or AVNRT if the ECG shows:
- •Normal complex tachycardia with abrupt onset and offset;
- •The RR interval remains relatively constant during tachycardia with heart rates of 220-310 bpm;
- •VA (ventriculo-atrial) association [i.e., there is a 1:1 AV relationship (except for cases of proven AV nodal reentry with a 2:1 relationship between atrium and ventricle)]; and
- •Termination of tachycardia with vagal maneuvres or adenosine with AV block or VA block.
- •Additional supportive information:
- •The presence of a P wave in either the ST segment or T wave, or the presence of a P wave altering the terminal portion of the QRS complex;
- •Spontaneous termination of the tachycardia with a P wave;
- •Onset with prolongation of the PR interval;
- •Altered rate with resolution of temporary bundle branch block;
- •Esophageal or electrophysiology study confirming tachycardia mechanism.
排除标准
- •Failure to obtain consent;
- •Known hypersensitivity to either study medication or suspension;
- •Structural heart disease other than a patent foramen ovale or patent ductus arteriosus;
- •Persistent abnormal cardiac function documented by echocardiogram (shortening fraction <28%) in sinus rhythm;
- •Pre-excitation (Wolff Parkinson White syndrome);
- •Permanent junctional reciprocating tachycardia;
- •Ectopic atrial tachycardia;
- •Atrial flutter;
- •Sick sinus syndrome or significant bradycardia;
- •Long QT syndrome;
- •Digoxin > 40 micrograms/kg total received within past 7 days
- •Amiodarone >50 milligrams/kg total received within past month
- •Asthma or obstructive airway disease;
- •Renal failure.
研究组 & 干预措施
Propranolol
Single dose of 0.5 mg/kg per dose and increased to 1.0 mg/kg per dose ITD for the second and subsequent doses.
干预措施: Propranolol (Drug)
Digoxin
First 2 doses at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses
干预措施: Digoxin (Drug)
结局指标
主要结局
Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.
时间窗: 6 months or until study endpoints were reached
次要结局
- Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin(12 months)
- Number of Treated Patients Experiencing First SVT Recurrence(up to 110 days of treatment)
研究者
Shubhayan Sanatani
principal investigator
University of British Columbia
