Preventing young women from developing cardiovascular disease (PHYLLIS study)

Home › Research and implementation › Our research areas › Maternity and perinatal mental health

Adopted project
20 July 2023 — adopted June 2023 • five-year study

Preventing young women from developing cardiovascular disease (PHYLLIS study)

Cardiovascular disease causes the greatest number of preventable deaths in the UK, with high rates in ethnic minority groups and the most deprived socioeconomic groups.

People from ethnic minority groups, deprived socioeconomic groups and women are disproportionately 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 at risk of cardiovascular disease to receive sodium glucose transport protein-2 inhibitors (SGLT2i) — a group of medicines shown to be effective at lowering blood glucose, improving weight loss and lowering blood pressure — alongside standard care. The study will particularly aim to recruit women from under-served communities.

How the study will be carried out

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

How patients and the public will be involved

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 PPIE 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 for participants, study-buddies, partners and community leaders

✓

Two PPI group members will be invited to the trial steering committee

✓

Africa Advocacy Foundation, BAME Health Collaborative, Ascension Trust and other local groups will promote the study through their social media networks, facilitate 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 — reducing trial length and cost

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 and 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.