Preventing young women from developing cardiovascular disease (PHYLLIS study)

People from ethnic minority groups, deprived socioeconomic groups and women are disproportionality under-represented in research. Pregnancy is a ‘physiological stress test’ revealing pre-dispositions to future cardiovascular and metabolic complications.

NICE guidelines for both hypertensive disorders of pregnancy and gestational diabetes recommend research into postpartum interventions which prevent future onset of cardiovascular disease, risk factors and recurrent pregnancy complications.

Addressing the challenges of engaging with high-risk women in the postpartum period (from immediately after childbirth up to six months later) and addressing inequalities, using novel approaches to identify early disease, engaging under-served communities and providing culturally acceptable, scalable and cost-effective interventions are urgently needed.

Project aim

This project aims to assess the feasibility of randomising postpartum women who are at risk of developing cardiovascular disease to receive sodium glucose transport protein-2 inhibitors (a group of medicines, which have been shown to be effective at lowering blood glucose levels, improving weight loss and lowering blood pressure) and standard care. The study will particularly aim to recruit women from under-served communities.

How the study will be carried out

This is a feasibility study for a randomised controlled trial. A prospective, parallel group, open-label, multicentred (3 centred), three-arm randomised controlled trial with a mixed methods evaluation.

How patients and the public will be involved in the study

Patient and public involvement and engagement (PPIE) input into the fellowship application was sought from: Africa Advocacy Foundation, BAME Health Collaborative, Ascension Trust, ARC South London Public Research Panel, Maternity service-users PPI group, Ethnic Minority Midwife group and individual women who were not part of a formal group.

Future patient and public involvement and engagement activities will include:

• PPI groups recruited at local sites (SE London/Manchester/Margate) from pre-existing and new networks will work with the research team with media support to develop engagement materials for postpartum health champion recruitment and training and participants, study-buddies, partners and community leaders engagement.
• Two PPI group members will be invited to the trial steering committee
• Other PPI partners, including Africa Advocacy Foundation, BAME Health Collaborative and Ascension Trust and other local groups will promote the study through their social media networks, and facilitate opportunities for engagement with local community leaders and support data dissemination and future trial design and delivery.

Potential benefits of the study

Short-term benefits:

• methodology developed in this fellowship can be adapted to deliver cost-effective community-based trials, supported by peer-educator and digital approaches.
• enhanced participation of under-served communities in research.
• identify people with early reversible vascular dysfunction most likely to benefit from intervention
• develop methods to study new endpoints using small rather than larger blood vessel changes for cardiovascular disease primary prevention studies to reduce trial length and cost, leading to interventions being available sooner

Long-term benefits:

If this approach is successful in large-scale trials, novel interventions could lead to:

• Prevention of 12,500 cases of hypertension in pregnant women per year and 17,500 new cases of Type-2 diabetes and associated management costs

• Reduced cardiovascular disease and health inequalities including in ethnic minority groups, socioeconomically deprived groups and pre-menopausal women
• Improved pregnancy outcomes for ethnic minorities, or people from deprived socioeconomic backgrounds through pre-pregnancy cardiovascular health optimisation.

The five- year study is funded by an NIHR fellowship for Dr Kate Bramham. It was adopted by ARC South London in June 2023.