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Peer-reviewedCC BY 4.0BMJ Open

PREGnancy, HEART Health and Cardiovascular Disease (PREG-HEART): protocol for a national, direct-to-participant prospective cohort study

  • Kathryn Hunt1
  • Rachel Buchan2,3
  • Claire Sheppard4
  • Rachel Cartwright5
  • Simon Fisher6
  • Rebecca Jarman7
  • Rebecca M Reynolds1
  • James S Ware2,3,5
  • Timothy James Ainsley Chico8,9,10
  • Deborah A Lawlor11,12
  • Antonio de Marvao2,13,14
  • Upasana Tayal3,5
14 affiliations
  1. 1Centre for Cardiovascular Science, Institute for Neuroscience and Cardiovascular Research, University of Edinburgh, Edinburgh, UK
  2. 2Medical Research Council Laboratory of Medical Sciences, Imperial College London, London, UK
  3. 3Royal Brompton and Harefield Hospitals, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
  4. 4Patient Representative, London, UK
  5. 5National Heart and Lung Institute, Imperial College London, London, UK
  6. 6NIHR-BHF Cardiovascular Partnership, University of Oxford, Oxford, UK
  7. 7Guy's and St Thomas’ NHS Foundation Trust, London, UK
  8. 8British Heart Foundation Data Science Centre, Health Data Research UK, London, UK
  9. 9NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals NHS Foundation Trust, The University of Sheffield, Sheffield, UK
  10. 10School of Medicine and Population Health, University of Sheffield, Sheffield, UK
  11. 11Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, UK
  12. 12Population Health Science, Bristol Medical School, University of Bristol, Bristol, UK
  13. 13Department of Women and Children’s Health, School of Life Course & Population Sciences, King’s College London, London, UK
  14. 14British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Medicine & Sciences, King’s College London, London, UK
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Abstract

Introduction: Cardiovascular disease is a leading cause of maternal and neonatal morbidity and mortality in the UK. Its prevalence in pregnancy continues to rise, driven by both improved survival of women with congenital and inherited heart disease into reproductive age and an increasing burden of acquired cardiovascular risk factors. However, its natural history and optimal management remain poorly defined. Current research is limited by small sample sizes, drawn from highly selected patient cohorts from individual units. The aim of the PREGnancy, HEART Health and Cardiovascular Disease (PREG-HEART) study is to develop a patient-driven, clinically relevant digital platform to understand the epidemiology of cardiovascular disease in pregnancy and support clinical trials of management strategies. This paper provides the protocol for PREG-HEART which will start with a 6-month pilot study.

Methods and analysis: PREG-HEART will use an online, direct-to-patient platform to enrol patients with cardiovascular disease in pregnancy alongside healthy pregnant controls. Enrolled women will be invited to provide self-reported demographic and clinical data and consent to linkage with national health records for long-term follow-up. We will also seek consent for storage and analysis of leftover clinical biosamples and to re-contact participants, enabling recruitment into sub-studies and clinical trials.

Planned analysis for the pilot study at 6 months will assess feasibility, including recruitment rates, case-mix of cardiovascular diagnoses, and participant geographical, socio-economic and ethnic background, compared with the UK general pregnant population. Findings from the pilot study will inform subsequent phases of PREG-HEART, which will explore associations between different cardiovascular diagnoses and adverse cardiovascular, obstetric and neonatal events. We will work closely with patients and clinicians to define priority research questions and use the PREG-HEART platform to support a range of observational and interventional studies to address these.

Ethics and dissemination: Approved by the West Midlands Solihull Research Ethics Committee (IRAS 349694; REC 25/WM/0142). Findings will be returned directly to participants, disseminated to clinicians through professional societies and the National Institute for Health and Care Research-British Heart Foundation Cardiovascular Partnership, and to the public through partner charities, as well as by peer-reviewed publication.

Trial registration number: ISRCTN11700499.

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Cite

BibTeXRIS
BibTeX
@article{hunt2026pregnancy,
  title = {{PREGnancy, HEART Health and Cardiovascular Disease (PREG-HEART): protocol for a national, direct-to-participant prospective cohort study}},
  author = {Kathryn Hunt and Rachel Buchan and Claire Sheppard and Rachel Cartwright and Simon Fisher and Rebecca Jarman and Rebecca M Reynolds and James S Ware and Timothy James Ainsley Chico and Deborah A Lawlor and Antonio de Marvao and Upasana Tayal},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-120202},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-120202},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - PREGnancy, HEART Health and Cardiovascular Disease (PREG-HEART): protocol for a national, direct-to-participant prospective cohort study
AU  - Kathryn Hunt
AU  - Rachel Buchan
AU  - Claire Sheppard
AU  - Rachel Cartwright
AU  - Simon Fisher
AU  - Rebecca Jarman
AU  - Rebecca M Reynolds
AU  - James S Ware
AU  - Timothy James Ainsley Chico
AU  - Deborah A Lawlor
AU  - Antonio de Marvao
AU  - Upasana Tayal
PY  - 2026
DA  - 2026/10/27
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-120202
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-120202
AB  - Introduction: Cardiovascular disease is a leading cause of maternal and neonatal morbidity and mortality in the UK. Its prevalence in pregnancy continues to rise, driven by both improved survival of women with congenital and inherited heart disease into reproductive age and an increasing burden of acquired cardiovascular risk factors. However, its natural history and optimal management remain poorly defined. Current research is limited by small sample sizes, drawn from highly selected patient cohorts from individual units. The aim of the PREGnancy, HEART Health and Cardiovascular Disease (PREG-HEART) study is to develop a patient-driven, clinically relevant digital platform to understand the epidemiology of cardiovascular disease in pregnancy and support clinical trials of management strategies. This paper provides the protocol for PREG-HEART which will start with a 6-month pilot study.  Methods and analysis: PREG-HEART will use an online, direct-to-patient platform to enrol patients with cardiovascular disease in pregnancy alongside healthy pregnant controls. Enrolled women will be invited to provide self-reported demographic and clinical data and consent to linkage with national health records for long-term follow-up. We will also seek consent for storage and analysis of leftover clinical biosamples and to re-contact participants, enabling recruitment into sub-studies and clinical trials.  Planned analysis for the pilot study at 6 months will assess feasibility, including recruitment rates, case-mix of cardiovascular diagnoses, and participant geographical, socio-economic and ethnic background, compared with the UK general pregnant population. Findings from the pilot study will inform subsequent phases of PREG-HEART, which will explore associations between different cardiovascular diagnoses and adverse cardiovascular, obstetric and neonatal events. We will work closely with patients and clinicians to define priority research questions and use the PREG-HEART platform to support a range of observational and interventional studies to address these.  Ethics and dissemination: Approved by the West Midlands Solihull Research Ethics Committee (IRAS 349694; REC 25/WM/0142). Findings will be returned directly to participants, disseminated to clinicians through professional societies and the National Institute for Health and Care Research-British Heart Foundation Cardiovascular Partnership, and to the public through partner charities, as well as by peer-reviewed publication.  Trial registration number: ISRCTN11700499.
SN  - 2044-6055
SN  - 2044-6055
ER  -