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NCT Number: NCT05683093

Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood

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.

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Key information

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location status: Recruiting

Location contact

Katie Suriano

CONTACT

[email protected]

01865 226845

About this study

Women who develop blood pressure problems during pregnancy are more likely to have high blood pressure (hypertension) in later life as well as heart attacks or strokes. The children born to the pregnancy also tend to have higher blood pressure and are often at increased risk of heart and blood vessel disease later in life. Previous work has shown that children born to pregnancies where the mother has high blood pressure have changes in their blood vessels, heart and brain that can be measured long before they develop high blood pressure or other clinical symptoms. By understanding the pattern of changes cross multiple parts of the body, over a lifetime, the investigators can identify how advanced the underlying disease is for an individual and how their disease is likely to develop over the next few years.

The aim of this study is to understand the heart and blood vessel changes of people born to a hypertensive pregnancy once they are in their 20s and 30s. The investigators then hope to use this information to develop new ways to prevent early onset heart and blood vessel disease in these people.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

For exclusion of MRI component only:

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

Treatment and study plan

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.

Primary outcomes

  1. Cardiac right ventricular mass

    Time frame: 30-40 years of old

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

Secondary outcomes

  1. Cardiac left ventricular mass

    Time frame: 30-40 years of old

    MRI assessment of cardiac left ventricular mass indexed to body surface area (in g and g/m^2)

  2. Cardiac right ventricular end-diastolic volume

    Time frame: 30-40 years of old

    MRI assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2)

  3. Cardiac right ventricular stroke volume

    Time frame: 30-40 years of old

    MRI assessment of cardiac right ventricular stroke volume indexed to body surface area (in ml and ml/m^2)

  4. Cardiac left ventricular end-diastolic volume

    Time frame: 30-40 years of old

    MRI assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2)

  5. Cardiac left ventricular stroke volume

    Time frame: 30-40 years of old

    MRI assessment of cardiac left ventricular stroke volume indexed to body surface area (in ml and ml/m^2)

  6. Cardiac right ventricular systolic function

    Time frame: 30-40 years of old

    Echocardiography and MRI assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (in cm) and right ventricular ejection fraction measured by cardiac MRI (in %)

  7. Cardiac left ventricular systolic function

    Time frame: 30-40 years of old

    Echocardiography and MRI assessment of left ventricular systolic function: left ventricular ejection fraction (in %)

  8. Cardiac right ventricular diastolic function

    Time frame: 30-40 years of old

    Echocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)

  9. Cardiac left ventricular diastolic function

    Time frame: 30-40 years of old

    Echocardiography assessment of left ventricular (LV) diastolic function: LV Doppler early/late diastolic mitral inflow velocity ratio (E/A) and LV early Doppler inflow velocity/peak early diastolic tissue velocity ratio (E/e')

  10. Morphology of the right ventricles

    Time frame: 30-40 years of old

    MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis

  11. Morphology of the left ventricles

    Time frame: 30-40 years of old

    MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis

  12. Aortic compliance

    Time frame: 30-40 years of old

    Aortic distensibility by MRI (in 10^-3 mmHg^-1) and aortic/central blood pressure by cuff measurement (in mmHg)

  13. Intra-hepatic lipid content, steatohepatitis and hepatic fibrosis

    Time frame: 30-40 years of old

    MRI assessment of the liver to quantify proton density fat fraction (in %) and fibro-inflammatory status from iron-corrected T1 (cT1 in ms)

  14. Renal function

    Time frame: 30-40 years of old

    MRI assessment of fibro-inflammatory status from T1 (in ms) and surrogate measure of blood perfusion from T2* (in ms) and volumes (in ml and ml/m^2)

  15. Oxygen uptake across sub-maximal and peak exercise

    Time frame: 30-40 years of old

    Cardiopulmonary exercise test to measure oxygen uptake (VO2 in ml/kg/min)

  16. Carbon dioxide exchange kinetics across sub-maximal and peak exercise

    Time frame: 30-40 years of old

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

  17. Retinal arteriolar structure

    Time frame: 30-40 years of old

    Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging

  18. Retinal venular structure

    Time frame: 30-40 years of old

    Central retinal venular equivalent (CRVE in μm) measured using retinal imaging

  19. Retinal arteriolar-to-venular diameter ratio (AVR)

    Time frame: 30-40 years of old

    The ratio of average retinal arteriolar diameter (CRAE in μm) and average retinal venous diameter (CRVE in μm) measured using retinal imaging

  20. Ear microvascular structure

    Time frame: 30-40 years of old

    Superior crus of anti-helix earlobe vascular caliber (in μm) measured using ear vascular imaging

  21. Lung function

    Time frame: 30-40 years of old

    The forced expiratory volume in one second (FEV1 in L), forced vital capacity (FVC in L), and the ratio of FEV1 to FVC (FEV1/FVC) measured using spirometry

  22. Objective measure of physical activity

    Time frame: 30-40 years of old

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

  23. Total white matter volume

    Time frame: 30-40 years of old

    Total white matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI

  24. Total grey matter volume

    Time frame: 30-40 years of old

    Total grey matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI

  25. Subcortical brain volume of thalamus

    Time frame: 30-40 years of old

    Subcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI

  26. Subcortical brain volume of hippocampus

    Time frame: 30-40 years of old

    Subcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI

  27. White matter hyperintensities volume

    Time frame: 30-40 years of old

    Total volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI

  28. White matter hyperintensities count

    Time frame: 30-40 years of old

    The number of white matter hyperintensities on T2-weighted sequence of brain MRI

  29. Cerebral vessel lumen diameter

    Time frame: 30-40 years of old

    Cerebral vessel lumen diameter (in μm) assessed on the time-of-flight sequence of brain MRI

  30. Cerebral vessel density

    Time frame: 30-40 years of old

    Cerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI

  31. Cerebral vessel tortuosity

    Time frame: 30-40 years of old

    The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI

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

    Time frame: 30-40 years of old

    Whole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain MRI

  33. Arterial cerebral blood volume fraction

    Time frame: 30-40 years of old

    Arterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI

  34. Circulating vascular endothelial growth factor A (VEGF-A) as an angiogenic marker

    Time frame: 30-40 years of old

    The level of VEGF-A (in pg/mL) measured from plasma blood samples

  35. Circulating soluble endoglin (sENG) as an angiogenic marker

    Time frame: 30-40 years of old

    The level of sENG (in ng/mL) measured from plasma blood samples

  36. Circulating soluble fms-like tyrosine kinase-1 (sFlt-1) as an antiangiogenic marker

    Time frame: 30-40 years of old

    The level of sFlt-1 (in pg/mL) measured from plasma blood samples

  37. Circulating total cholesterol as a metabolic marker

    Time frame: 30-40 years of old

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

  38. Circulating high-density lipoprotein as a metabolic marker

    Time frame: 30-40 years of old

    The level of HDL (in mmol/L) measured from serum blood samples

  39. Circulating low-density lipoprotein as a metabolic marker

    Time frame: 30-40 years of old

    The level of LDL (in mmol/L) measured from serum blood samples

  40. Circulating triglycerides as a metabolic marker

    Time frame: 30-40 years of old

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

  41. Circulating fasting glucose concentration as a metabolic marker

    Time frame: 30-40 years of old

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

  42. Circulating fasting insulin concentration as a metabolic marker

    Time frame: 30-40 years of old

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

  43. Insulin resistance index (HOMA-IR) as a metabolic marker

    Time frame: 30-40 years of old

    The index calculated as fasting glucose (in mmol/L) x fasting insulin (in μIU/mL) ÷ 22.5

  44. Circulating C-reactive protein (CRP) as an inflammatory marker

    Time frame: 30-40 years of old

    The level of CRP (in mmol/L) measured from serum blood samples

  45. Circulating soluble intercellular adhesion molecule-1 (sICAM-1) as an inflammatory marker

    Time frame: 30-40 years of old

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

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

    Time frame: 30-40 years of old

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

  47. Body weight

    Time frame: 30-40 years of old

    Body weight measured in kg

  48. Body height

    Time frame: 30-40 years of old

    Body height measured in m

  49. Body mass index

    Time frame: 30-40 years of old

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

  50. Mid-arm circumference

    Time frame: 30-40 years of old

    Mid-arm circumference measured in cm

  51. Waist-to-hip ratio

    Time frame: 30-40 years of old

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

  52. Systolic blood pressure

    Time frame: 30-40 years of old

    Resting brachial blood pressure measurement (in mmHg)

  53. Diastolic blood pressure

    Time frame: 30-40 years of old

    Resting brachial blood pressure measurement (in mmHg)

  54. Mean arterial pressure

    Time frame: 30-40 years of old

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

  55. Pulse pressure

    Time frame: 30-40 years of old

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

  56. Heart rate

    Time frame: 30-40 years of old

    The frequency of the heart contractions per minute (in beats per minute or bpm)

  57. Smoking status

    Time frame: 30-40 years of old

    The number and percentage of current smokers

  58. Alcohol consumption

    Time frame: 30-40 years of old

    Weekly alcoholic unit intake (in units per week)

Study contacts

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

Katie Suriano

CONTACT

[email protected]

01865 226845

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • University of Bristol

Registry information

Official study title

Cardiovascular Longitudinal the Avon Longitudinal Study of Parents and Children (ALSPAC) Research Investigations Following Hypertensive Pregnancy in Young Adulthood

Acronym: CLARITY

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 12, 2023
Registry last updated
Jan 12, 2023

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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