The HEART-BEAT Clinic Study

The HEART-BEAT (Heart Evaluation and Assessment in Reproductive Transition – Biomarkers, Echocardiography, Adaptation, & Trajectories) Clinic Study

Registry ID
ISRCTN10176972
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Enrollment
800
Start date
2026-07-01
Completion date
2046-05-01
Last update
2026-08-17

Conditions

Summary

Cardiac disease or cardiac risk factors in pregnancy

Detailed description

Participants will be asked for consent to extract data from their electronic health record for research purposes. This will include records from both the Pregnancy Heart Clinic and other services, including maternity services and neonatal services, that they access. Consent will cover data extraction from the electronic medical record of both mother and baby for up to 1 year after delivery. Participants will be asked to complete validated questionnaires (e.g., Cambridge Worry Scale, Generalized Anxiety Disorder-7) at their Pregnancy Heart Clinic attendances. Participants will also be asked to complete bespoke questionnaires regarding their patient experience. Participants will not be asked to complete more than two x 10 minute questionnaires per visit. Participants will also be asked for permission to link their study data (patient only) to routinely-collected data sources, including NHS (e.g. Hospital Episode Statistics, primary care data). Participants will also be asked to consent to being contacted about other ethically approved studies either (i) during their pregnancy or (ii) after pregnancy. These may involve participating in qualitative interviews or completing additional questionnaires. During pregnancy, add-on studies may involve additional testing arranged during clinic visits, for example, 6-minute walk tests or data collection from wearable heart monitors (‘smart watches’), which are for research purposes and will not be used to inform clinical care. Specific ethical approval and consent will be obtained for each ‘add-on’ study either during or after pregnancy.

Interventions

Inclusion criteria

1. Women referred to a regional cardiac service because they have cardiac disease or cardiac risk factors 2. Women who are currently pregnant, have been pregnant within the past year, or are intending to become pregnant

Exclusion criteria

1. Less than 16 years of age 2. Anyone who lacks the capacity to consent

Locations

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View on source registry