Cardiovascular disease in pregnancy Circulatory System
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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