FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 41
- 主要终点
- Proportion of live-born children with a delivery at term and a normal cardiac rhythm
研究概览
简要总结
The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth.
详细描述
Few studies are specifically designed to address health concerns relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally fast heart rate up to 300 beats per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby (fetus). Although fetal SVA, including AF and other forms of SVT, is the most common cause of intended in-utero fetal therapy, our knowledge of drug effects on the baby and the co-treated mother is still limited. The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial to address this knowledge gap in order to guide future patient management to the best of care.
FAST Trial components include:
- A prospective Registry (FAST Registry; see this document) as well as
- Three prospective Randomized Clinical Trials (FAST RCTs; see ClinicalTrials.gov #NCT02624765).
The FAST Registry is a prospective observational cohort study to determine the impact of different prenatal treatment strategies on patients diagnosed with fetal AF without hydrops, AF with hydrops, SVT without hydrops, and SVT with hydrops. All management decisions including the choice of antiarrhythmic medication or the decision to observe without treatment are at the discretion of the treating physician. The primary outcome measure will be the proportion of term deliveries of live-born children with a normal cardiac rhythm. Secondary outcome measures include the efficacy of 1st line, 2nd line, 3rd line, and maintenance drug therapy in controlling the different arrhythmias prior to birth and patient safety.
Participation of a site in the FAST Registry requires experience with the perinatal management of fetal AF and SVT, local REB/IRB approval and an executed legal contract with the Hospital for Sick Children, Toronto.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mother has provided written informed consent to participate
- •Fetal AF or SVT with or without hydrops
- •Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:
- •Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes or longer
- •Tachycardia ≥ 170 bpm during +100% of time (≤ 30 0/7 weeks of gestation)
- •Tachycardia ≥ 280 bpm (irrespective of SVA duration)
- •SVT with fetal hydrops (irrespective of duration)
- •Gestational age <36 0/7 weeks at time of enrollment
- •Singleton Pregnancy
- •Healthy mother with ± normal pre-treatment cardiovascular findings:
- •ECG within normal range (sinus rhythm; QTc ≤ 0.47; PR ≤ 0.2 sec; QRS: ≤ 0.12 sec; insignificant anomalies; isolated premature beats; isolated complete right bundle
- •Maternal resting heart rate ≥ 50 bpm
- •Maternal systolic BP ≥ 85 mmHg
排除标准
- •Primary delivery for postnatal cardioversion
- •Antiarrhythmic fetal treatment for more than 2 days at time of enrollment
- •Any maternal-fetal conditions associated with high odds of premature delivery and/or death
- •History of significant maternal heart condition (open heart surgery; sick sinus syndrome; long QT, Brugada syndrome; ventricular tachycardia; WPW syndrome; high-degree heart block; cardiomyopathy)
结局指标
主要结局
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
时间窗: Term: 37 0/7 to 41 6/7 weeks
次要结局
- Proportion of participants with treatment failure(From date of treatment start until the date of first documented fetal cardioversion or until the date of treatment failure, whichever comes first, assessed up to 30 gestational weeks)
- Total days of treatment related maternal and neonatal hospitalizations(From date of diagnosis or treatment begin to 30 days of life)
- Proportion of patients with cardioversion over time(From date of SVA dignosis until the date of first documented cardioversion or until the date of delivery/fetal death without cardioversion, whichever comes first, assessed up to 30 gestational weeks)
- Average gestational age at birth(At birth)
- Proportion of participants with arrhythmia-related death(From date of arrhythmia diagnosis or date of treatment start to 30 days of life)
- Birth weight (z-scores; centiles)(At birth)
- Maternal prevalence of pregnancy/treatment-related AEs and outcomes(Diagnosis to birth)
- Maternal prevalence of adverse events and outcome(From date of treatment begin to 30 days of life)
研究者
Edgar Jaeggi
Senior Associate Scientist Emeritus Edgar Jaeggi, MD FRCPC
The Hospital for Sick Children