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NCT Number: NCT06187012

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

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.

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Key information

Conditions

Hypertension Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Attributes Disease Progression Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Oxford Department of Cardiovascular Medicine

Oxford, OX3 9DU, United Kingdom

Location status: Recruiting

Location contact

Katie Suriano

CONTACT

[email protected]

01865226845

Paul Leeson, PhD MRCP FESC

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

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

  2. 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

    Magnetic resonance imaging assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (ml/m^2)

  3. 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

    Magnetic resonance imaging assessment of cardiac right ventricular stroke volume indexed to body surface area (ml/m^2).

  4. 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

    Magnetic resonance imaging assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (ml/m^2).

  5. 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

    Magnetic resonance imaging assessment of cardiac left ventricular stroke volume indexed to body surface area (ml/m^2).

  6. 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

    Echocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (cm).

  7. 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

    Magnetic resonance imaging assessment of right ventricular ejection fraction measured by cardiac magnetic resonance imaging (%).

  8. 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

    Echocardiography assessment of left ventricular systolic function

  9. 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

    Magnetic resonance imaging assessment of left ventricular ejection fraction (%).

  10. 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

    Echocardiography assessment of right ventricular doppler early/late diastolic tricuspid inflow velocity ratio (E/A)

  11. 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

    Echocardiography assessment of left ventricular doppler early/late diastolic mitral inflow velocity ratio (E/A).

  12. 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

    Echocardiography assessment of left ventricular early doppler inflow velocity/peak early diastolic tissue velocity rate (E/e').

  13. 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

    Magnetic resonance imaging assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis.

  14. 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

    Magnetic resonance imaging assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis.

  15. 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 distensibility by magnetic resonance imaging (10^-3 mmHg-1).

  16. 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

    Aortic/central blood pressure by cuff measurement (mmHg).

  17. 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

    Magnetic resonance imaging assessment of the liver to quantify proton density fat fraction (%).

  18. 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

    Magnetic resonance imaging assessment of the liver to quantify fibro-inflammatory status from iron corrected T1 (cT1 in ms)

  19. 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

    Magnetic resonance imaging assessment of renal volumes (ml/m^2).

  20. 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

    Magnetic resonance imaging assessment of fibro-inflammatory status from T1 (ms)

  21. 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

    Magnetic resonance imaging assessment of surrogate measures of blood perfusion from T2* (in ms).

  22. 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

    Cardiopulmonary exercise test to measure oxygen uptake (ml/kg/min).

  23. 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

    Cardiopulmonary exercise test to measure respiratory exchange ratio (RER) calculated as carbon dioxide production divided by oxygen consumption.

  24. 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

    Central retinal arteriolar equivalent (CRAE) in micrometres measured using retinal imaging.

  25. 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

    Central retinal venular equivalent (micrometres) measured using retinal imaging.

  26. 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

    The ratio of average retinal arteriolar diameter and average retinal venous diameter (micrometres).

  27. 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

    Superior crus of anti-helix earlobe vascular calibre (micrometres) measured using ear vascular imaging.

  28. 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

    The ratio of FEV1 to FVC (FEV1/FVC) measured using spirometry.

  29. 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

    The forced vital capacity (FVC in L) measured using spirometry.

  30. 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

    The forced expiratory volume in one second (FEV1 in L) measured using spirometry.

  31. 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

    The amount of vigorous physical activity (h/week) measured using wrist worn accelerometer.

  32. 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

    The amount of moderate to vigorous physical activity (h/week) measured using wrist worn accelerometer.

  33. 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 white matter volumes (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.

  34. 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

    Total grey matter volumes (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.

  35. 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 thalamus (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.

  36. 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

    Subcortical brain volume of hippocampus (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging.

  37. 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

    Total volume of white matter hyperintensities (mm3) assessed on T2-weighted sequence of brain magnetic resonance imaging.

  38. 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

    Total number of white matter hyperintensities on T2-weighted sequence of brain magnetic resonance imaging.

  39. 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 lumen diameter (micrometres) assessed on the time-of-flight sequence of brain magnetic resonance imaging.

  40. 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

    The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain magnetic resonance imaging.

  41. Cerebral vessel density

    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 density (mm3) assessed on the time-of-flight sequence of brain magnetic resonance imaging.

  42. Whole brain grey matter perfusion or cerebral blood flow (CBF)

    Time frame: 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/CBF (in ml/100g/min) assessed on arterial spin labelling of brain magnetic resonance imaging.

  43. Arterial cerebral blood volume fraction

    Time frame: 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 (%) assessed on arterial spin labelling on brain magnetic resonance imaging.

  44. Circulating vascular endothelial growth factor A as an angiogenic marker

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

    The level of circulating vascular endothelial growth factor A (pg/mL) measured from plasma blood samples.

  45. Circulating soluble endoglin as an angiogenic marker.

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

    The level of circulating soluble endoglin (ng/mL) measured from plasma blood samples.

  46. Circulating soluble fms-like tyrosine kinase-1 as an angiogenic marker.

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

    The level of circulating soluble fms-like tyrosine kinase-1 measured from plasma blood samples.

  47. Circulating total cholesterol as a metabolic marker

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

    The level of total cholesterol (mmol/L) measured from serum blood samples.

  48. Circulating high-density lipoprotein as a metabolic marker

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

    The level of circulating high-density lipoprotein (mmol/L) measured from serum blood samples.

  49. Circulating low-density lipoprotein as a metabolic marker

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

    The level of circulating low-density lipoprotein (mmol/L) measured from serum blood samples.

  50. Circulating triglycerides as a metabolic marker

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

    The level of circulating triglycerides (mmol/L) measured from serum blood samples.

  51. Circulating fasting glucose concentration as a metabolic marker

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

    The level of fasting glucose (mmol/L) measured from whole blood samples.

  52. Circulating fasting insulin concentration as a metabolic marker

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

    The level of fasting insulin (pmol/L) measured from serum blood samples.

  53. Insulin resistance index as a metabolic marker

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

    The index calculated as fasting glucose (mmol/L) x fasting insulin (ulU/mL)/22.5.

  54. Circulating C-reactive protein as an inflammatory marker.

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

    The level of circulating C-reactive protein (mmol/L) measured from serum blood samples.

  55. Circulating soluble intercellular adhesion molecule-1 (slCAM-1) as an inflammatory marker

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

    The level of sICAM-1 (ng/mL) measured from serum blood samples.

  56. Circulating soluble vascular adhesion molecule-1 (sVCAM-1) as an inflammatory marker

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

    The level of sVCAM-1 (ng/mL) measured from serum blood samples.

  57. Body weight

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

    Body weight (kg)

  58. Body height

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

    Body height (m).

  59. Body mass index (BMI)

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

    Body weight divided by the square of height (kg/m2).

  60. Mid-arm circumference

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

    Mid-arm circumference (cm).

  61. Waist-to-hip ratio

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

    The ratio of waist circumference (cm) to hip circumference (cm).

  62. Systolic blood pressure

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

    Resting brachial blood pressure measurement (mmHg).

  63. Diastolic blood pressure

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

    Resting brachial blood pressure measurement (mmHg).

  64. Mean arterial pressure.

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

    The average arterial pressure from resting brachial blood pressure measurement (mmHg).

  65. Pulse pressure

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

    The difference between systolic and diastolic blood pressure (mmHg).

  66. Heart rate

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

    The frequency of the heart contractions per minute (bpm).

  67. Smoking status

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

    The number and percentage of current smokers.

  68. Alcohol consumption

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

    Weekly alcoholic unit intake (units per week).

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Suriano

CONTACT

[email protected]

01865226845

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)

Acronym: HELPFUL

Important dates

Study start
2023
Primary completion
2027
Study completion
2042
First posted
Jan 2, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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