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

June 13, 2013
May 23, 2016
August 2011
September 2017   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01888770 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
  • 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
 
The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood, serum, plasma
Non-Probability Sample
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.
  • Preeclampsia
  • Preterm Birth
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
September 2017
September 2017   (final data collection date for primary outcome measure)

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)
Both
up to 6 Months   (Child)
No
Contact: Paul Leeson, PhD, FRCP +44(0)1865572846 paul.leeson@cardiov.ox.ac.uk
United Kingdom
 
NCT01888770
EPOCH
No
Not Provided
Not Provided
University of Oxford
University of Oxford
British Heart Foundation
Principal Investigator: Paul Leeson, PhD, FRCP University of Oxford Department of Cardiovascular Medicine
University of Oxford
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP