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The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health (EPOCH)

2016年5月23日更新者：University of Oxford

The purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy.

研究概览

地位

未知

条件

详细说明

While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.

The investigators have therefore designed the EPOCH study to investigate whether those individuals born to hypertensive pregnancies and/or to a preterm birth demonstrate differences in the cardiovascular phenotype at birth, or whether they develop any differences over the first three months of life and whether this varies with other perinatal factors. This study also allows investigation of the short term impact of perinatal interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype in this population.

研究类型

观察性的

注册 (预期的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

英国
- Oxfordshire
  - Oxford、Oxfordshire、英国、OX3 9DU
    - 招聘中
    - Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
    - 接触：
      
      Paul Leeson, PhD, MRCP
      
      邮箱：paul.leeson@cardiov.ox.ac.uk
    - 首席研究员：
      
      Paul Leeson, PhD, FRCP

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 6个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Study population is drawn from infants admitted to or delivered in the OUH NHS Foundation trust to normotensive or hypertensive pregnancies across a range of gestations. The mothers of these infants form a secondary study cohort.

描述

Inclusion Criteria:

Available for assessment within the neonatal period,
Parent is willing and able to give informed consent for participation in the study,
Physical condition is suitable to allow non-invasive vascular testing,
Mother meets criteria for inclusion in the study and is willing to participate in the study. (Aged >/= 16 years and Is able and willing to give informed consent for participation in the study, and is able and willing to give informed consent for her infants participation in the study. )
Cases: Diagnosed during pregnancy with preeclampsia or gestational hypertension and/or delivered preterm (<37 weeks gestation)
Controls: No history of gestational hypertension or preeclampsia during this pregnancy and delivered at term (>37 weeks gestation)

Exclusion Criteria:

Parent is unwilling to give consent,
Unavailable for assessment of cardiovascular system,
Physical condition unsuitable to allow for non-invasive testing of cardiovascular system,
Evidence of congenital cardiovascular disease (with the exception of Persistent Patent Ductus Arterious (PDA) and Atrial Septal Defect (ASD)),
Cardiorespiratory instability at time of proposed measures,
Active infection at time of proposed study measures,
Mother of infant is excluded from the study. (Aged <16 years, unable or unwilling to consent to study or Physical condition post delivery such that it would preclude participation in the study)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Normotensive Term Infants born at term (>37 weeks) to Normotensive pregnancies
Term Preeclampsia Infants born at term (>37 weeks gestation) and exposed to a preeclamptic pregnancy
Preterm Normotensive Infants born to Normotensive pregnancies at <37 weeks gestation
Preterm Hypertensive Infants born to hypertensive pregnancies at <37 weeks completed gestation
Term Pregnancy-induced Hypertension Infants born at term (>37 weeks gestation) and exposed to pregnancy-induced hypertension

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Systolic Cardiac Function 大体时间：Birth and 3 months	Cardiac Function will be assessed by ECHO at birth and 3 months	Birth and 3 months

次要结果测量

结果测量	措施说明	大体时间
Micro-vascular Structure 大体时间：Birth and 3 months	Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months (as capillary density at baseline)	Birth and 3 months
Pulse wave velocity and pulse-wave analysis 大体时间：Birth and 3 months		Birth and 3 months
Cardiac Structure 大体时间：Birth and 3 months	Cardiac structure will be assessed by echocardiography at in utero, at birth and 3 months (as left and right ventricular mass)	Birth and 3 months
Cardiac diastolic function 大体时间：Birth and 3 months	Cardiac Function will be assessed by ECHO at birth and 3 months	Birth and 3 months
Blood pressure 大体时间：Birth and 3 months		Birth and 3 months
Heart rate variability 大体时间：Birth and 3 months	Heart rate variability will be assessed by a 5 minute electrocardiogram	Birth and 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Oxford

合作者

British Heart Foundation

调查人员

首席研究员：Paul Leeson, PhD, FRCP、University of Oxford Department of Cardiovascular Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年8月1日

初级完成 (预期的)

2017年9月1日

研究完成 (预期的)

2017年9月1日

研究注册日期

首次提交

2013年6月13日

首先提交符合 QC 标准的

2013年6月25日

首次发布 (估计)

2013年6月28日

研究记录更新

最后更新发布 (估计)

2016年5月25日

上次提交的符合 QC 标准的更新

2016年5月23日

最后验证

2016年5月1日