EPIC

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Principal Investigator/s:

Dr Fionnuala Mone

Dr Chris Watson

Dr Kelly Reilly

Name of the Study:

EPIC-Elucidating a common Pathophysiology between pre-eclampsia and fetal and maternal Impairment in Cardiac function – a cohort study

Why is this Study important?

Pre-eclampsia (high blood pressure and protein in the urine) and cardiac disease remain within the top ten causes of maternal mortality in the UK and perinatal congenital cardiac disease is one of the most significant contributors to neonatal death, collectively affecting over 2000 pregnancies per annum in Northern Ireland. There is a recent hypothesis to suggest that pre-eclampsia is a cardiovascular disease in origin as well as evidence to suggest an association between pre-eclampsia and fetal cardiac defects. To attempt to elucidate the pathophysiology of such disease further we propose a prospective case-control study looking at the biomarkers potentially associated with disease pathogenesis and progression. The cohorts will include: (i) women with pre-eclampsia and respective controls; (ii) pregnant women with congenital or acquired cardiac disease; (iii) pregnant women carrying fetuses with a prenatal diagnosis of cardiac compromise in-utero or a congenital cardiac defect at risk of in-utero or neonatal progression to cardiac failure. Through prediction of disease onset and progression we can then tailor management plans and therapies to optimise outcome. We also aim to assess ophthalmic artery doppler and the morphometric measurements of the retinal blood vessels in this unique cohort. New research shows links between abnormal ophthalmic artery assessment, retinal vasculature assessment and pre-eclampsia. The links between ophthalmic/retinal vasculature morphology and cardiovascular disease have also been demonstrated but not in pregnant women with pre-existing cardiovascular disease or with a fetus with a congenital cardiac defect.

What is the Research question/aim?:

We aim to further investigate these links to support our theory that pre-eclampsia has a predominantly cardiovascular origin. We aim to determine if ophthalmic artery doppler and conjunctival vessel imaging can help to predict pre-eclampsia and cardiovascular risk. We also aim to determine if there is an association between pre-eclampsia and heart disease biomarkers inclusive of LRG-1 and if there are a combination of biomarkers which are more predictive.

What the Study involves:

We will approach pregnant women at the Royal Jubilee Maternity Service who are attending the heart clinic as they have had a difference in their heart either from birth or developing later in life. We will also approach women attending the fetal medicine centre as a paediatric cardiologist has confirmed the presence of a difference in the baby’s heart. We will also reach out to women who do not themselves or their fetuses have heart disease so we can compare groups. Once couples have had a chance to read the patient information leaflet and consider partaking, we will obtain written consent and aim to take a blood sample from the mother and perform a heart scan in all mothers and detailed scans of blood flow and heart function in the baby in all those cases where the baby has a heart difference. We will also conduct the images and blood flow checks of the mother’s eyes which will require taking a photographic image of the eye and applying an ultrasound probe adjacent to the maternal forehead to check the blood flow through the main vessel to the eye. Following delivery in babies with heart differences a blood sample will be taken from the cord/placenta and the placenta will be sent to the laboratory for analysis as well as being taken from babies with any signs of deteriorating heart function to coincide with other blood tests they are already having in the neonatal unit or follow-up clinic. In addition, for any women who undergo a needle test in pregnancy (amniocentesis) to test baby’s DNA we will request if we can store any residual amniotic fluid for testing. Testing for the aforementioned biomarkers will be performed at Queen’s University Belfast and any residual samples will be stored under secure conditions with testing performed for differences in genetics before and after delivery as well as any identified future biomarkers identified for which ethical approval has been obtained.

Who can take part in the Study?

We aim to recruit mothers who have a known heart condition either developed in life or from birth, who are pregnant. We will also aim to recruit a separate group of women whose babies have been identified in this pregnancy as having a heart condition.