Recipient organisationKing's College Hospital NHS Foundation Trust
Funding£305K
PeriodJun 2025 — Dec 2027
In plain English
AI plain-English summary
A hundred and eight women who develop dangerously high blood pressure during pregnancy will be randomly assigned to one of two common antihypertensive drugs—enalapril or a calcium channel blocker—to see whether a large-scale trial comparing these treatments after childbirth is feasible. Cardiovascular disease kills more women in the UK than any other cause, and a hypertensive pregnancy raises that risk sharply. Yet no one has determined the best way to manage blood pressure in the months after birth, when women are juggling infant care and may be breastfeeding. This feasibility study tests whether home blood-pressure monitors, culturally matched healthcare champions, and flexible scheduling can overcome the barriers that keep new mothers—especially those from ethnic minority and deprived backgrounds—out of cardiovascular research. If the approach works, it could pave the way for a definitive trial that directly informs postnatal treatment guidelines. That would mean clearer, evidence-based choices for clinicians and patients, potentially reducing the disproportionate burden of heart disease and stroke that falls on women who have had hypertensive pregnancies. The study also gathers data on kidney function, heart structure, and retinal blood vessels, helping future researchers select meaningful short-term endpoints instead of waiting decades for heart attacks or strokes to occur.
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Background: Cardiovascular disease is the leading cause of death of women in the UK. Ethnic minority groups and those with socioeconomic deprivation are worst affected and are typically under-represented in research. Hypertensive disorders of pregnancy affect 10% of UK pregnancies and are strongly associated with subsequent cardiovascular diseases, including death and stroke. Pregnancy and the postnatal period may be an optimal opportunity to reduce inequity in future cardiovascular disease burden through early interventions. Optimal postnatal management of cardiovascular health has not yet been determined and postnatal studies pose unique challenges. Women with young children may find it difficult to participate, and drug interventions need to consider breastfeeding. Use of innovative surrogate and intermediate endpoints (e.g. blood pressure/ endothelial dysfunction) for younger women (rather than costly and lengthy assessment of traditional long-term primary outcomes) will help address evidence gaps. PHYLLIS is an NIHR-funded feasibility study exploring novel engagement strategies (healthcare champions, home-based testing, study-buddies) for postnatal women with cardiovascular risk factors and will assess recruitment of women randomised after completing breastfeeding to take dapagliflozin or standard care. In an efficient design, we propose utilising PHYLLIS infrastructure to offer an additional intervention between recruitment (during pregnancy) and starting dapagliflozin (after finishing breastfeeding) to better understand optimisation of postnatal cardiovascular health. Aims: To assess feasibility and acceptability of a randomised, open-label study of angiotensin-converting-enzyme inhibitor (enalapril), versus calcium channel blockers (nifedipine/amlodipine) after pregnancy complicated by hypertension. To optimise study design to enhance participation of individuals from under-served communities in maternal cardiovascular studies To collect data to inform future trial design of postnatal hypertension management, including choice of endpoints. Methods: Design: Multicentre, open-label randomised feasibility study; Population: 108 women; Four sites (Margate, London x2, Manchester). Inclusion criteria: Women diagnosed with hypertensive disorder of pregnancy requiring postnatal antihypertensive treatment. Randomisation: 1:1; Minimisation by hypertensive disorder of pregnancy (chronic, other) and severity (≥2 vs. 0-1 antihypertensive agents) at consent. Intervention: Enalapril vs. calcium channel blocker (nifedipine or amlodipine) (in accordance with NICE guidelines) to maintain blood pressure <140/<90mmHg. Study processes: Healthcare champions will provide culturally congruent support; Participants will be given validated automated blood pressure machines for home readings. Primary outcome: Recruitment rate (per site per month). Process outcomes: Acceptability, retention rate, healthcare resource use. Clinical outcomes: Blood pressure, echocardiographic, renal and optical coherence tomography-angiography parameters. Time-frame: From randomisation (during pregnancy or immediately after birth) to 16-weeks postnatal. Timelines for delivery: Months 1-4: Material co-development, study set- up. Months 5–24: Recruitment, data collection. Months 24-30: Analysis, dissemination. Anticipated Impact and Dissemination: Participants will be sent regular progress updates progress and co-created results will be communicated to all participants. Academic outputs will be disseminated through peer-reviewed journals, international conferences and through social media to primary and secondary care. Anticipated impact of this study is to support larger studies which could: a) inform postnatal antihypertensive treatment guidelines; b) improve engagement in preventative postnatal care; c) reduce the disproportionate burden of cardiovascular disease and pregnancy complications on individuals, communi
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