Understanding long-term heart health in women after hypertensive pregnancies
Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)
University of Oxford · NCT06187012
This study looks at why women who had high blood pressure during pregnancy might face heart problems later in life by comparing their health to women who had normal pregnancies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Oxford (other) |
| Locations | 1 site (Oxford) |
| Trial ID | NCT06187012 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate why women who have experienced high blood pressure during pregnancy are at an increased risk of developing cardiovascular diseases later in life. By analyzing data from women 10 to 25 years postpartum, the study will assess changes in the heart, brain, and blood vessels over time. The researchers will compare women with hypertensive pregnancies to those with normotensive pregnancies to identify patterns of disease progression. Advanced imaging and machine learning models will be utilized to understand the interconnectedness of these changes across different body systems.
Who should consider this trial
Good fit: Ideal candidates are women who had a pregnancy 10 to 25 years ago and experienced high blood pressure during that pregnancy.
Not a fit: Patients who are currently pregnant or have significant chronic diseases affecting cardiovascular health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and prevention strategies for cardiovascular diseases in women with a history of hypertensive pregnancies.
How similar studies have performed: Other studies have shown that understanding the long-term effects of hypertensive pregnancies can lead to better health outcomes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion Criteria * Participant is willing and able to give informed consent for participation in the study * Female who had a pregnancy 10 to 25 years prior * Able (in the investigator's opinion) and willing to comply with all study requirements. * Adequate understanding of verbal and written English Exclusion Criteria: * The participant may not enter the study if ANY of the following apply: * Over 10 weeks pregnant during the course of the study * Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status * Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study For exclusion of MRI component only: • Unsuitable for MRI based on the responses to the MRI screening form. The participant may still be included in other parts of the study.
Where this trial is running
Oxford
- University of Oxford Department of Cardiovascular Medicine — Oxford, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Paul Leeson — University of Oxford
- Study coordinator: Katie Suriano
- Email: helpful@cardiov.ox.ac.uk
- Phone: 01865226845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Cardiovascular Diseases, Cerebrovascular Disorders, Vascular Diseases, Hypertensive pregnancy, Older adults, Pre-eclampsia, Gestational hypertension