{ "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.\n\nMethods 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.\n\nPlanned 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.\n\nEthics 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.\n\nTrial registration number: ISRCTN11700499.", "abstract_shown": true, "affiliations": [ "Centre for Cardiovascular Science, Institute for Neuroscience and Cardiovascular Research, University of Edinburgh, Edinburgh, UK", "Medical Research Council Laboratory of Medical Sciences, Imperial College London, London, UK", "Royal Brompton and Harefield Hospitals, Guy’s and St Thomas’ NHS Foundation Trust, London, UK", "Patient Representative, London, UK", "National Heart and Lung Institute, Imperial College London, London, UK", "NIHR-BHF Cardiovascular Partnership, University of Oxford, Oxford, UK", "Guy's and St Thomas’ NHS Foundation Trust, London, UK", "British Heart Foundation Data Science Centre, Health Data Research UK, London, UK", "NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals NHS Foundation Trust, The University of Sheffield, Sheffield, UK", "School of Medicine and Population Health, University of Sheffield, Sheffield, UK", "Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, UK", "Population Health Science, Bristol Medical School, University of Bristol, Bristol, UK", "Department of Women and Children’s Health, School of Life Course & Population Sciences, King’s College London, London, UK", "British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Medicine & Sciences, King’s College London, London, UK" ], "article_type": "research article", "arxiv": null, "author_total": 12, "authors": [ { "affs": [ 0 ], "name": "Kathryn Hunt" }, { "affs": [ 1, 2 ], "name": "Rachel Buchan" }, { "affs": [ 3 ], "name": "Claire Sheppard" }, { "affs": [ 4 ], "name": "Rachel Cartwright" }, { "affs": [ 5 ], "name": "Simon Fisher" }, { "affs": [ 6 ], "name": "Rebecca Jarman" }, { "affs": [ 0 ], "name": "Rebecca M Reynolds" }, { "affs": [ 1, 2, 4 ], "name": "James S Ware" }, { "affs": [ 7, 8, 9 ], "name": "Timothy James Ainsley Chico" }, { "affs": [ 10, 11 ], "name": "Deborah A Lawlor" }, { "affs": [ 1, 12, 13 ], "name": "Antonio de Marvao", "orcid": "0000-0001-9095-5887" }, { "affs": [ 2, 4 ], "name": "Upasana Tayal" } ], "bibtex": "https://research.draconitic.com/paper/c3n4q9swer4br.bib", "cited_by": 0, "doi": "10.1136/bmjopen-2026-120202", "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13723820/", "id": "c3n4q9swer4br", "issns": [ "2044-6055", "2044-6055" ], "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-120202", "language": "en", "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "1506" ], [ "heading", "1683" ], [ "heading", "Cardiovascular Medicine" ], [ "heading", "Protocol" ], [ "openalex", "2705|Cardiovascular Issues in Pregnancy" ] ], "openalex": "W7223805191", "pdf_url": null, "pmcid": "PMC13723820", "pmid": "42946357", "published": "2026-10-27", "publisher": "BMJ", "ris": "https://research.draconitic.com/paper/c3n4q9swer4br.ris", "sources": [ { "first_seen": "2026-10-30T12:19:44Z", "native_id": "10.1136/bmjopen-2026-120202", "source": "crossref", "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-120202" }, { "first_seen": "2026-11-04T12:22:23Z", "native_id": "PMC13723820", "source": "pmc", "url": "https://doi.org/10.1136/bmjopen-2026-120202" } ], "subjects": [ { "field": "medicine", "origin": "heading:Cardiovascular Medicine", "subfield": "cardiovascular" } ], "title": "PREGnancy, HEART Health and Cardiovascular Disease (PREG-HEART): protocol for a national, direct-to-participant prospective cohort study", "title_text": "PREGnancy, HEART Health and Cardiovascular Disease (PREG-HEART): protocol for a national, direct-to-participant prospective cohort study", "type": "peer-reviewed", "updated_at": "2026-11-05T12:20:34Z", "url": "https://research.draconitic.com/paper/c3n4q9swer4br", "venue": "BMJ Open", "versions": [] }