Hypertension Explored in Long-term Postpartum Follow-up in Later Life

NCT ID: NCT06187012

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2042-11-01

Brief Summary

The purpose of this study is to understand more about why women who have had hypertensive pregnancies may be at increased risk of high blood pressure and why these women are often at increased risk of heart and blood vessel disease later in life.

Detailed Description

Women who experience high blood pressure during pregnancy are at increased risk of developing cardiac and vascular diseases later in life. They show changes in their heart, brain, and blood vessels long before they develop high blood pressure. The investigators therefore think that these changes develop slowly over the course of the life of the woman and establish their risk of later disease.

Through better understanding of the pattern of changes across multiple parts of the body over extended periods of time, the investigators aim to identify how advanced the underlying disease is for an individual and how the disease is likely to develop over the next few years. By comparing the rate of change across different parts of the body, the investigators can examine how one area affects another.

Data including images of the heart, brain and blood vessels will be acquired in women 10 to 25 years after their pregnancy. The initial analysis will focus on assessing differences between women who have had a normotensive pregnancy and those who have had a hypertensive pregnancy, both at a single timepoint and in changes within individuals over time.

This dataset will then be used in conjunction with previously acquired data in women who have experienced a hypertensive pregnancy to find out how patterns emerge across the whole body. The investigators will subsequently combine information from different measures at the same time and use the machine learning models to learn the patterns of change that occur as a person progresses from a healthy to a diseased state.

This will allow the researchers to identify patterns of hypertensive disease development and it may open doors to better interventions and therapies tailored towards individuals.

Conditions

Hypertension; Cardiovascular Diseases; Cerebrovascular Disorders; Vascular Diseases

Study Design

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

Study Groups

Hypertensive pregnancy

Hypertensive pregnancy

Intervention Type: OTHER

Participants will attend one visit lasting approximately 3-4 hours on a single day or split over multiple visits to complete all measures. Participants will first be asked to provide written informed consent for the study. Participants' anthropometric measures (waist-to-hip ratio, height and weight, hip and waist circumference and left arm circumference and resting blood pressures will then be taken. After this, the participants will undergo cardiopulmonary exercise testing, followed by magnetic resonance imaging, echocardiography, retinal imaging and vascular imaging of the ear. The study visit will conclude with participants being provided with a wrist-worn physical activity monitor to wear for 7-9 days following the visit. These monitors will provide objective measures of physical activity while people go about their normal activities.

Interventions

Hypertensive pregnancy

Participants will attend one visit lasting approximately 3-4 hours on a single day or split over multiple visits to complete all measures. Participants will first be asked to provide written informed consent for the study. Participants' anthropometric measures (waist-to-hip ratio, height and weight, hip and waist circumference and left arm circumference and resting blood pressures will then be taken. After this, the participants will undergo cardiopulmonary exercise testing, followed by magnetic resonance imaging, echocardiography, retinal imaging and vascular imaging of the ear. The study visit will conclude with participants being provided with a wrist-worn physical activity monitor to wear for 7-9 days following the visit. These monitors will provide objective measures of physical activity while people go about their normal activities.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Leeson

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

University of Oxford Department of Cardiovascular Medicine

Oxford, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Katie Suriano

Role: CONTACT

helpful@cardiov.ox.ac.uk

01865226845

Facility Contacts

Katie Suriano

Role: primary

helpful@cardiov.ox.ac.uk

01865226845

Other Identifiers

22/LO/0781

Identifier Type: -

Identifier Source: org_study_id