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

NCT06187012 | Recruiting

• 1 other identifier: 22/LO/0781
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases; Hypertension; Cardiovascular Diseases; Cerebrovascular Disorders

Keywords

Hypertensive pregnancy; Older adults; Pre-eclampsia; Gestational hypertension; Cardiovascular risk; Disease progression; Longitudinal

Outcome Measures

Primary Outcomes (1)

• Cardiac right ventricular mass

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

  Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy. Index pregnancy is defined as the pregnancy which we first collected data from.

Secondary Outcomes (68)

• Cardiac left ventricular mass

  Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy

• Cardiac right ventricular end-diastolic volume

  Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy

• Cardiac right ventricular stroke volume.

  Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy

• Cardiac left-ventricular end-diastolic volume.

  Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy

• Cardiac left ventricular stroke volume

  Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy

Study Arms (1)

Hypertensive pregnancy

Other: Hypertensive pregnancy

Interventions

Hypertensive pregnancy 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.

Hypertensive pregnancy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Females only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will study a group of 200 women at 10 to 25 years postpartum to extend data coverage over time and to ensure a broad representation of hypertensive disease state during mid-life in women. This will be achieved by a follow-up of participants from a previous study called Preeclampsia Vascular Study (PVS) (08/H0604/127). These women were originally seen at 5 to 15 years post-index hypertensive or normotensive pregnancy. If required, the investigators will restart their identification and recruitment methods, previously used in PVS, based on obstetric records to identify, and recruit additional women who had pregnancies 10 to 25 years prior, to ensure that the sample size is reached. All participants will undergo a standardised imaging protocol as described in the general overview.

You may qualify if:

• 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

You may not qualify if:

• 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
• Unsuitable for MRI based on the responses to the MRI screening form. The participant may still be included in other parts of the study.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford Department of Cardiovascular Medicine

Oxford, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Cerebrovascular Disorders; Vascular Diseases; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Disease Progression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Leeson

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Suriano

CONTACT

01865226845; helpful@cardiov.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 40 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 2, 2024
• Study Start: March 23, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2042
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)