Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood

NCT05683093 | Recruiting

• 1 other identifier: 22/WA/0227
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Young Adult; Birth History; Hypertension in Pregnancy; Cardiovascular Risk; Exercise Capacity

Outcome Measures

Primary Outcomes (1)

• Cardiac right ventricular mass

  Magnetic resonance imaging (MRI) assessment of cardiac right ventricular mass indexed to body surface area (in g and g/m\^2)

  30-40 years of old

Secondary Outcomes (58)

• Cardiac left ventricular mass

  30-40 years of old

• Cardiac right ventricular end-diastolic volume

  30-40 years of old

• Cardiac right ventricular stroke volume

  30-40 years of old

• Cardiac left ventricular end-diastolic volume

  30-40 years of old

• Cardiac left ventricular stroke volume

  30-40 years of old

Interventions

History of being born to hypertensive or normal pregnancy OTHER

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.

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Of the 200 young adults followed up from the ALSPAC study, 100 will have been born to a hypertensive pregnancy and 100 following an uncomplicated pregnancy. At time of follow-up, they will be 30 to 40 years of age. At the 25-year follow-up in Bristol, there were 610 individuals born to hypertensive pregnancies.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• University of Bristol: collaborator

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension; Cardiovascular Diseases; Cerebrovascular Disorders; Vascular Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Adam J Lewandowski

  Cardiovascular Clinical Research Facility

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Suriano

CONTACT

01865 226845; clarity@cardiov.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: January 12, 2023
• Study Start: November 17, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)