Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood

NCT ID: NCT05683093

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2027-01-31

Brief Summary

The purpose of this study is to understand more about why young people who were born to a hypertensive pregnancy may have increased risk of high blood pressure and are often at increased risk of heart and blood vessel disease later in life.

Detailed Description

Women who develop blood pressure problems during pregnancy are more likely to have high blood pressure (hypertension) in later life as well as heart attacks or strokes. The children born to the pregnancy also tend to have higher blood pressure and are often at increased risk of heart and blood vessel disease later in life. Previous work has shown that children born to pregnancies where the mother has high blood pressure have changes in their blood vessels, heart and brain that can be measured long before they develop high blood pressure or other clinical symptoms. By understanding the pattern of changes cross multiple parts of the body, over a lifetime, the investigators can identify how advanced the underlying disease is for an individual and how their disease is likely to develop over the next few years.

The aim of this study is to understand the heart and blood vessel changes of people born to a hypertensive pregnancy once they are in their 20s and 30s. The investigators then hope to use this information to develop new ways to prevent early onset heart and blood vessel disease in these people.

Conditions

Young Adult; Hypertension in Pregnancy; Hypertension; Cardiovascular Diseases; Cerebrovascular Diseases; Vascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

History of being born to hypertensive or normal pregnancy

CLARITY is an observational study whereby participants will attend one 4-hr visit the Division of Cardiovascular Medicine, University of Oxford at the John Radcliffe Hospital in Oxford, with the option to split the study visit over two days for convenience.

Participants will be invited by the ALSPAC study team to attend a study visit in Oxford where the investigators will use MRI and other imaging modalities to study the brain, heart, liver, kidneys, and vasculature using standardised protocols. A dataset including information from previous follow-up of these cohorts and the detailed pregnancy data available within ALSPAC will be generated by the study team in Bristol and integrated with available data from the Oxford cohorts.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study
• Male or female, aged 30 to 40 years at time of enrolment
• Participant previously took part in the ALSPAC study
• Able (in the investigator's opinion) and willing to comply with all study requirements
• Adequate understanding of verbal and written English

Exclusion Criteria

• Pregnant or lactating when they are due to attend for study visit 1
• Less than six months postpartum
• Planning to donate blood within two weeks prior to study visit 1
• Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study
• Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status

For exclusion of MRI component only:

• Unsuitable for MRI based on participant screening; the participant may still be included in other parts of the study

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bristol

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam J Lewandowski

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Clinical Research Facility

Locations

University of Oxford

Oxford, Oxfordshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Katie Suriano

Role: CONTACT

clarity@cardiov.ox.ac.uk

01865 226845

Facility Contacts

Katie Suriano

Role: primary

clarity@cardiov.ox.ac.uk

01865 226845

Other Identifiers

22/WA/0227

Identifier Type: -

Identifier Source: org_study_id