Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Oxford
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01888770
First received: June 13, 2013
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
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.

Condition
Preeclampsia
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Systolic Cardiac Function [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Cardiac Function will be assessed by ECHO at birth and 3 months


Secondary Outcome Measures:
  • Micro-vascular Structure [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months (as capillary density at baseline)

  • Pulse wave velocity and pulse-wave analysis [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
  • Cardiac Structure [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Cardiac structure will be assessed by echocardiography at in utero, at birth and 3 months (as left and right ventricular mass)

  • Cardiac diastolic function [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Cardiac Function will be assessed by ECHO at birth and 3 months

  • Blood pressure [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Heart rate variability will be assessed by a 5 minute electrocardiogram


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma

Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888770

Contacts
Contact: Paul Leeson, PhD, FRCP +44(0)1865572846 paul.leeson@cardiov.ox.ac.uk

Locations
United Kingdom
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Paul Leeson, PhD, MRCP       paul.leeson@cardiov.ox.ac.uk   
Principal Investigator: Paul Leeson, PhD, FRCP         
Sponsors and Collaborators
University of Oxford
British Heart Foundation
Investigators
Principal Investigator: Paul Leeson, PhD, FRCP University of Oxford Department of Cardiovascular Medicine
  More Information

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01888770     History of Changes
Other Study ID Numbers: EPOCH 
Study First Received: June 13, 2013
Last Updated: May 23, 2016
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Premature Birth
Pre-Eclampsia
Hypertension
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016