The Effect of Preeclampsia and Gestational Hypertension on Offspring Cardiovascular Health (EPOCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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: July 1, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to investigate whether exposure to preeclampsia or gestational hypertension before birth results 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 Preeclampsia and Gestational Hypertension on Offspring Cardiovascular Health

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Cardiac Function [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Cardiac Structure 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

  • Micro-vascular function [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Micro-vascular Function will be assessed using using Side Stream Dark Field (SDF) imaging device at birth and 3 months

  • 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 birth and 3 months


Other Outcome Measures:
  • Blood Pressure [ Time Frame: Birth and 3 months ] [ Designated as safety issue: No ]
    Blood pressure will be assessed at birth and 3months

  • Macrovascular structure [ Time Frame: Birth to 3 months ] [ Designated as safety issue: No ]
    Macrovascular structure will be assessed by ultrasound at birth and 3 months


Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma


Estimated Enrollment: 200
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 Hypertensive
Infants born at term (>37 weeks gestation) to hypertensive pregnancies
Preterm Normotensive
Infants born to Normotensive pregnancies at <37 weeks gestation
Preterm Hypertensive
Infants born to hypertensive pregnancies at <37 weeks completed gestation

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 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 such as degree of prematurity. 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population is drawn from infants delivered in the OUH hospital trust to normotensive or hypertensive pregnancies. 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
  • Controls: No history of gestational hypertension or preeclampsia during this, or any previous pregnancy.

Exclusion Criteria:

  • Parent is unwilling to give consent,
  • Unavailable for assessment of vascular function,
  • Physical condition unsuitable to allow for non-invasive testing of endothelial function,
  • Evidence of congenital cardiovascular disease (with the exception of Persistent Ductus Arteriosus (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

No publications provided

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: July 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 26, 2014