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

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.

Study Overview

• Status: Unknown
• Conditions: Preterm Birth; Preeclampsia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Paul Leeson, PhD, FRCP; Phone Number: +44(0)1865572846; Email: paul.leeson@cardiov.ox.ac.uk

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Recruiting
      • Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
      • Contact: Paul Leeson, PhD, MRCP; Email: paul.leeson@cardiov.ox.ac.uk
      • Principal Investigator: Paul Leeson, PhD, FRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Cardiac Function	Cardiac Function will be assessed by ECHO at birth and 3 months	Birth and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Micro-vascular Structure	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		Birth and 3 months
Cardiac Structure	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	Cardiac Function will be assessed by ECHO at birth and 3 months	Birth and 3 months
Blood pressure		Birth and 3 months
Heart rate variability	Heart rate variability will be assessed by a 5 minute electrocardiogram	Birth and 3 months

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: British Heart Foundation
• Investigators: Principal Investigator: Paul Leeson, PhD, FRCP, University of Oxford Department of Cardiovascular Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: June 13, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hypertension, Pregnancy-Induced; Toxemia; Hypertension; Premature Birth; Pre-Eclampsia
• Other Study ID Numbers: EPOCH