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A UK-wide, direct-to-patient platform for studying cardiovascular disease in pregnancy

PREG-HEART: PREGnancy, HEART health and cardiovascular disease longitudinal study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11700499
Enrollment
200
Registered
2025-11-26
Start date
2025-11-25
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease in pregnancy Circulatory System

Interventions

Participants will be invited to register on the online PREG-HEART platform, provide consent electronically, and enter self-reported demographics and health data relevant to their cardiovascular diagno

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adult (age 16 years and over) 2. Registered with a GP in the UK 3. Capacity to provide informed consent For those enrolling as participants with cardiovascular disease (cases): 1. Any history of pregnancy, either current or previous (with pregnancy defined as a positive pregnancy test and/or ultrasound confirmed pregnancy) 2. Self-reported confirmed diagnosis of cardiac disease which predates pregnancy, or was newly diagnosed during pregnancy or within 6 months postpartum, including: 2.1. Ventricular dysfunction (cardiomyopathies, heart failure of any aetiology) 2.2. Valvular heart disease (including previous valve replacement) 2.3. Congenital cardiac lesions (including following surgical correction of congenital lesion) 2.4. Arrhythmia (cardiac conduction defects and arrhythmias history of previous cardiac ablation, inherited arrhythmia syndromes) 2.5. Coronary artery disease 2.6. Systemic hypertension 2.7. Pulmonary hypertension 2.8. Aortic disease 2.9. Connective tissue disease (heritable collagen, elastin, or glycosaminoglycan disorders, autoimmune connective tissue diseases and vasculitides) 2.10. Thromboembolic disease 2.11. Other relevant long-term cardiac diagnoses as determined by the study investigators 2.12. Carriers of (pathogenic) genetic variants associated with cardiovascular conditions For those enrolling as participants without cardiac disease (controls): 1. Currently pregnant (with pregnancy defined as a positive pregnancy test and/or ultrasound confirmed pregnancy) 2. No diagnosed cardiac disease, as defined by the conditions listed above

Exclusion criteria

Exclusion criteria: 1. Patients who lack capacity to consent for themselves 2. People who do not have access to the Internet and/or who are unable to provide an email address for study correspondence

Design outcomes

Primary

MeasureTime frame
The primary outcome is to evaluate the feasibility of direct-to-patient recruitment to a longitudinal cohort study of cardiovascular disease in pregnancy. This will be measured by assessing the following after a 6-month pilot period, and annually thereafter: 1. Number of participants (cases and controls) successfully recruited, baseline questionnaire completion rate, and number of biosamples provided 2. The primary self-reported cardiovascular diagnoses of recruited participants, compared to estimated UK prevalences based on nationally reported data

Secondary

MeasureTime frame
Pregnancy outcome data for recruited participants (collected through participant-report and/or linkage to national registries and medical records), compared to nationally reported outcome data for women with cardiovascular disease. This will be assessed at the end of the initial 6-month pilot period, and annually thereafter.

Countries

United Kingdom

Contacts

Public ContactUpasana Tayal
preg-heart@imperial.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026