HypertensionHELPFULNCT06187012
Hypertension Explored in Long-term Postpartum Follow-up in Later Life
An observational study of Hypertension and Cardiovascular Diseases, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Hypertension, Cardiovascular Diseases, Cerebrovascular Disorders
- What is being tested?
- Hypertensive pregnancy
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2023to 1 Nov 2042
- How long will I take part?
- 40 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford Department of Cardiovascular Medicine
Oxford, OX3 9DU
Katie Suriano, 01865226845, helpful@cardiov.ox.ac.uk
Paul Leeson, PhD MRCP FESC
About this study
Official title: Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)
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.
Read the 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.
- Being tested
- Hypertensive pregnancy
- Keywords
- Hypertensive pregnancy, Older adults, Pre-eclampsia, Gestational hypertension, Cardiovascular risk, Disease progression, Longitudinal
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Cerebrovascular Disorders, Vascular Diseases, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertensive pregnancyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive pregnancy | Not described Receives: Other: Hypertensive pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac right ventricular mass
Magnetic resonance imaging assessment of cardiac right ventricular mass indexed to body surface area (g/m^2).
Measured: 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
Magnetic resonance imaging assessment of cardiac left ventricular mass indexed to body surface area (g/m^2).
Measured: 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
Magnetic resonance imaging assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (ml/m^2)
Measured: 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.
Magnetic resonance imaging assessment of cardiac right ventricular stroke volume indexed to body surface area (ml/m^2).
Measured: 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.
Magnetic resonance imaging assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (ml/m^2).
Measured: 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
Magnetic resonance imaging assessment of cardiac left ventricular stroke volume indexed to body surface area (ml/m^2).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac right ventricular systolic function
Echocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (cm).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac right ventricular ejection fraction
Magnetic resonance imaging assessment of right ventricular ejection fraction measured by cardiac magnetic resonance imaging (%).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular systolic function
Echocardiography assessment of left ventricular systolic function
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular ejection fraction
Magnetic resonance imaging assessment of left ventricular ejection fraction (%).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac right ventricular diastolic function
Echocardiography assessment of right ventricular doppler early/late diastolic tricuspid inflow velocity ratio (E/A)
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular diastolic function
Echocardiography assessment of left ventricular doppler early/late diastolic mitral inflow velocity ratio (E/A).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular diastolic function
Echocardiography assessment of left ventricular early doppler inflow velocity/peak early diastolic tissue velocity rate (E/e').
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Morphology of the right ventricles
Magnetic resonance imaging assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Morphology of the left ventricles
Magnetic resonance imaging assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Aortic distensibility
Aortic distensibility by magnetic resonance imaging (10^-3 mmHg-1).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Aortic compliance
Aortic/central blood pressure by cuff measurement (mmHg).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Intra-hepatic liquid content and steatohepatitis
Magnetic resonance imaging assessment of the liver to quantify proton density fat fraction (%).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Hepatic fibrosis
Magnetic resonance imaging assessment of the liver to quantify fibro-inflammatory status from iron corrected T1 (cT1 in ms)
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Renal volumes
Magnetic resonance imaging assessment of renal volumes (ml/m^2).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Renal fibro-inflammatory status
Magnetic resonance imaging assessment of fibro-inflammatory status from T1 (ms)
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Renal blood perfusion
Magnetic resonance imaging assessment of surrogate measures of blood perfusion from T2* (in ms).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Oxygen uptake across submaximal exercise
Cardiopulmonary exercise test to measure oxygen uptake (ml/kg/min).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Carbon dioxide exchange kinetics across submaximal exercise
Cardiopulmonary exercise test to measure respiratory exchange ratio (RER) calculated as carbon dioxide production divided by oxygen consumption.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Retinal arteriolar structure
Central retinal arteriolar equivalent (CRAE) in micrometres measured using retinal imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Retinal venular structure
Central retinal venular equivalent (micrometres) measured using retinal imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Retinal arteriolar-to venule diameter ratio (AVR)
The ratio of average retinal arteriolar diameter and average retinal venous diameter (micrometres).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Ear microvascular structure.
Superior crus of anti-helix earlobe vascular calibre (micrometres) measured using ear vascular imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Lung function
The ratio of FEV1 to FVC (FEV1/FVC) measured using spirometry.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Lung capacity
The forced vital capacity (FVC in L) measured using spirometry.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Lung volume
The forced expiratory volume in one second (FEV1 in L) measured using spirometry.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Objective measure of vigorous physical activity.
The amount of vigorous physical activity (h/week) measured using wrist worn accelerometer.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Objective measure of moderate to vigorous physical activity.
The amount of moderate to vigorous physical activity (h/week) measured using wrist worn accelerometer.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Total white matter volume
Total white matter volumes (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Total grey matter volume
Total grey matter volumes (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Subcortical brain volume of thalamus
Subcortical brain volume of thalamus (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Subcortical brain volume of hippocampus
Subcortical brain volume of hippocampus (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
White matter hyperintensities volume
Total volume of white matter hyperintensities (mm3) assessed on T2-weighted sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
White matter hyperintensities count
Total number of white matter hyperintensities on T2-weighted sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cerebral vessel lumen diameter
Cerebral vessel lumen diameter (micrometres) assessed on the time-of-flight sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cerebral vessel tortuosity
The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cerebral vessel density
Cerebral vessel density (mm3) assessed on the time-of-flight sequence of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Whole brain grey matter perfusion or cerebral blood flow (CBF)
Whole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Arterial cerebral blood volume fraction
Arterial cerebral blood volume fraction (%) assessed on arterial spin labelling on brain magnetic resonance imaging.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating vascular endothelial growth factor A as an angiogenic marker
The level of circulating vascular endothelial growth factor A (pg/mL) measured from plasma blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating soluble endoglin as an angiogenic marker.
The level of circulating soluble endoglin (ng/mL) measured from plasma blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating soluble fms-like tyrosine kinase-1 as an angiogenic marker.
The level of circulating soluble fms-like tyrosine kinase-1 measured from plasma blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating total cholesterol as a metabolic marker
The level of total cholesterol (mmol/L) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating high-density lipoprotein as a metabolic marker
The level of circulating high-density lipoprotein (mmol/L) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating low-density lipoprotein as a metabolic marker
The level of circulating low-density lipoprotein (mmol/L) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating triglycerides as a metabolic marker
The level of circulating triglycerides (mmol/L) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating fasting glucose concentration as a metabolic marker
The level of fasting glucose (mmol/L) measured from whole blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating fasting insulin concentration as a metabolic marker
The level of fasting insulin (pmol/L) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Insulin resistance index as a metabolic marker
The index calculated as fasting glucose (mmol/L) x fasting insulin (ulU/mL)/22.5.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating C-reactive protein as an inflammatory marker.
The level of circulating C-reactive protein (mmol/L) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating soluble intercellular adhesion molecule-1 (slCAM-1) as an inflammatory marker
The level of sICAM-1 (ng/mL) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Circulating soluble vascular adhesion molecule-1 (sVCAM-1) as an inflammatory marker
The level of sVCAM-1 (ng/mL) measured from serum blood samples.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Body weight
Body weight (kg)
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Body height
Body height (m).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Body mass index (BMI)
Body weight divided by the square of height (kg/m2).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Mid-arm circumference
Mid-arm circumference (cm).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Waist-to-hip ratio
The ratio of waist circumference (cm) to hip circumference (cm).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Systolic blood pressure
Resting brachial blood pressure measurement (mmHg).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Diastolic blood pressure
Resting brachial blood pressure measurement (mmHg).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Mean arterial pressure.
The average arterial pressure from resting brachial blood pressure measurement (mmHg).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Pulse pressure
The difference between systolic and diastolic blood pressure (mmHg).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Heart rate
The frequency of the heart contractions per minute (bpm).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Smoking status
The number and percentage of current smokers.
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Alcohol consumption
Weekly alcoholic unit intake (units per week).
Measured: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start23 Mar 2023
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 40 Years
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Leeson, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187012
- Sponsor's protocol ID
- 22/LO/0781
- Acronym
- HELPFUL
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)
- ClinicalTrials.gov ID
- NCT06187012
- Acronym / sponsor ID
- HELPFUL / 22/LO/0781
- Keywords
- Hypertensive pregnancy, Older adults, Pre-eclampsia, Gestational hypertension, Cardiovascular risk, Disease progression, Longitudinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2042 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 40 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive pregnancy | – | Other: Hypertensive pregnancy |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
- The participant may not enter the study if ANY of the following apply:
- Unsuitable for MRI based on the responses to the MRI screening form. The participant may still be included in other parts of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertensive pregnancyParticipants 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. | Other | Hypertensive pregnancy |
Primary outcome
Cardiac right ventricular mass
Time frame: 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.
Magnetic resonance imaging assessment of cardiac right ventricular mass indexed to body surface area (g/m^2).
68 secondary outcomes
Cardiac left ventricular mass
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac right ventricular systolic function
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac right ventricular ejection fraction
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular systolic function
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular ejection fraction
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac right ventricular diastolic function
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular diastolic function
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cardiac left ventricular diastolic function
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Morphology of the right ventricles
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Morphology of the left ventricles
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Aortic distensibility
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Aortic compliance
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Intra-hepatic liquid content and steatohepatitis
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Hepatic fibrosis
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Renal volumes
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Renal fibro-inflammatory status
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Renal blood perfusion
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Oxygen uptake across submaximal exercise
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Carbon dioxide exchange kinetics across submaximal exercise
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Retinal arteriolar structure
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Retinal venular structure
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Retinal arteriolar-to venule diameter ratio (AVR)
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Ear microvascular structure.
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Lung function
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Lung capacity
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Lung volume
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Objective measure of vigorous physical activity.
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Objective measure of moderate to vigorous physical activity.
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Total white matter volume
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Total grey matter volume
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Subcortical brain volume of thalamus
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Subcortical brain volume of hippocampus
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
White matter hyperintensities volume
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
White matter hyperintensities count
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cerebral vessel lumen diameter
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Cerebral vessel tortuosity
Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Leeson principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiovascular Diseases, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Suriano (01865226845, helpful@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac right ventricular mass (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.