POstNatal Cardiovascular Health OutcomeS (PONCHOS)
Research type
Research Study
Full title
Observational study of postnatal cardiovascular health following pre-eclampsia
IRAS ID
286831
Contact name
Jenny Myers
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This study builds on previous data, which have highlighted the relationship between pre-eclampsia and postnatal cardiovascular dysfunction, remodelling and long-term cardiovascular risk. The feasibility study PICk-UP demonstrated an improvement in cardiac remodelling and diastolic function following 6 months’ treatment with enalapril compared with placebo. It is not known whether these changes persist beyond cessation of the intervention and whether there is any association between baseline characteristics (including pre-eclampsia phenotype and early postnatal echocardiography and biomarkers measures) and long-term cardiovascular profile.
Current UK clinical practice guidelines recommend counselling preeclamptic women about their increased cardiovascular risk and encouraging healthy lifestyle change. However, evidence of clinician awareness and practice of post-pre-eclampsia follow-up is lacking in the UK. Similarly, there is limited knowledge of how women with prior preeclampsia perceive and understand their personal cardiovascular risk.
This study aims to provide novel longitudinal data on blood pressure and cardiovascular function and remodelling in this high-risk group, compared with the background population. Although underpowered to determine a difference in cardiovascular phenotype between treatment allocations, this study will allow early exploration of any potential lasting effect of the intervention (enalapril) on cardiovascular function, remodelling and risk. It will also provide important information on clinician and patient understanding of cardiovascular risk and management following pre-eclampsia.
This study also aims to improve our understanding of UK clinicians' awareness and practice of post-pre-eclampsia cardiovascular health optimisation.
This is a prospective observational cohort study. Women who previously participated in PICk-UP and Tommy's will be approached via letter and/or telephone and invited to take part in this study. In both these studies, women previously consented to be contacted by the research team in the future. Women will attend a single research visit at St Mary’s hospital, where they will complete a questionnaire and undergo echocardiography, blood pressure and bloods.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
22/WM/0085
Date of REC Opinion
19 May 2022
REC opinion
Further Information Favourable Opinion