Clinical trial NCT01888770: The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
Official title: The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Preterm Birth
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2013-06-28
Enrollment: 300
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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)

Primary outcomes:
measure: Systolic Cardiac Function
timeFrame: Birth and 3 months
Secondary outcomes:
measure: Micro-vascular Structure
timeFrame: Birth and 3 months
measure: Pulse wave velocity and pulse-wave analysis
timeFrame: Birth and 3 months
measure: Cardiac Structure
timeFrame: Birth and 3 months
measure: Cardiac diastolic function
timeFrame: Birth and 3 months
measure: Blood pressure
timeFrame: Birth and 3 months
measure: Heart rate variability
timeFrame: Birth and 3 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford Department of Cardiovascular Medicine
name: Paul Leeson, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: