Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 27
- 主要终点
- Freedom from cardiac death ≥1 year of life
研究概览
简要总结
Few studies are specifically designed to address health concerns that are already 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 slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.
详细描述
The SLOW HEART REGISTRY is a multi-centered prospective observational study of fetuses diagnosed with high-degree immune-mediated atrio-ventricular heart block (AVB). The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.
The study aims are to document the outcome of patients diagnosed prenatally with immune-mediated 2nd or 3rd degree AVB irrespective of the primary choice of prenatal care.
The primary objective will be to determine the rate of transplant-free survival to 1 year of life of fetuses with AVB based on the prenatal management decision:
- Cohort 1: Fetuses not treated with fluorinated glucocorticoids
- Cohort 2: Fetuses treated with fluorinated glucocorticoids from the time of immune-mediated AVB diagnosis.
Secondary objectives will be to determine:
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
- •Written informed maternal consent to participate in the Slow Heart Registry
- •High-degree (2nd; 2:1; 2nd-3rd or 3rd degree) AVB diagnosed ≤ 32+0 weeks with or without hydrops
- •Enrollment within maximally 8 days of high-degree AVB diagnosis
- •Positive or pending anti-Ro/La antibody test results at the time of enrollment
排除标准
- •AVB associated with major CHD (e.g. left atrial isomerism, cc-TGA)
- •AVB with known negative anti-Ro and/or La antibody test result at enrollment
- •1st degree AVB
- •Sinus bradycardia with normal 1:1 AV conduction
- •Blocked atrial bigeminy (irregular atrial rate with failure of AV conduction of the premature atrial beat)
- •Primary delivery for postnatal treatment
- •Maternal-fetal conditions (other than cardiac NL) associated with high odds of premature delivery or death (e.g. renal failure, significant infectious diseases, major extracardiac anomalies, PROM, etc.)
- •Preexisting maternal mental disorder (e.g. bipolar, mania, severe depression, substance abuse)
- •Poorly controlled insulin-dependent diabetes (HbA1c >7%) at CAVB diagnosis
- •Oligohydramnios (deepest/maximal vertical pocket <2 cm)
- •Severe IUGR (estimated fetal weight <3rd percentile)
研究组 & 干预措施
Prospective observational cohort 1
Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
干预措施: Dexamethasone (Drug)
Prospective observational cohort 1
Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
干预措施: No Dexamethasone (Other)
Prospective observational cohort 2
Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
干预措施: Dexamethasone (Drug)
Prospective observational cohort 2
Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
干预措施: No Dexamethasone (Other)
结局指标
主要结局
Freedom from cardiac death ≥1 year of life
时间窗: up to 12 months
次要结局
- Proportion of participants with change in prenatal treatment(up to 6 months)
- Proportion of maternal serious adverse events and outcomes(Fetal diagnosis to 12 months)
- Average birth weight(Birth)
- Prevalence of significant heart failure (HF score, echo, HF treatment) at 1 year of life(12 months)
- Proportion of participants with fetal and neonatal death and their causes/factors(1 month)
- Proportion of secondarily treated patients (initially untreated group 1 cases)(up to 6 months)
- Freedom from permanent pacemaker implantation from birth to 1 year of life(Birth to 12 months)
- Proportion of serious pregnancy outcomes (IUFD, IUGR <3rd percentile, delivery <35 weeks)(up to 6 months)
- Proportion of patients/group with progression from incomplete to complete AVB by 1 year(Fetal diagnosis to 12 months)
- Average gestational age at birth(Birth)
- Proportion of children with moderate/severe neuro-developmental delay at 12-18 months(12-18 months)
研究者
Edgar Jaeggi
Senior Associate Scientist Emeritus
The Hospital for Sick Children