University of Oxford
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
NCT Number: NCT05683093
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.
Interested in participating?
Request Info30 year–40 year
All sexes
Observational
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For exclusion of MRI component only:
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.
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)
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)
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)
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)
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)
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)
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 %)
Time frame: 30-40 years of old
Echocardiography and MRI assessment of left ventricular systolic function: left ventricular ejection fraction (in %)
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)
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')
Time frame: 30-40 years of old
MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis
Time frame: 30-40 years of old
MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis
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)
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)
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)
Time frame: 30-40 years of old
Cardiopulmonary exercise test to measure oxygen uptake (VO2 in ml/kg/min)
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)
Time frame: 30-40 years of old
Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging
Time frame: 30-40 years of old
Central retinal venular equivalent (CRVE in μm) measured using retinal imaging
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
Time frame: 30-40 years of old
Superior crus of anti-helix earlobe vascular caliber (in μm) measured using ear vascular imaging
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
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
Time frame: 30-40 years of old
Total white matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI
Time frame: 30-40 years of old
Total grey matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI
Time frame: 30-40 years of old
Subcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI
Time frame: 30-40 years of old
Subcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI
Time frame: 30-40 years of old
Total volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI
Time frame: 30-40 years of old
The number of white matter hyperintensities on T2-weighted sequence of brain MRI
Time frame: 30-40 years of old
Cerebral vessel lumen diameter (in μm) assessed on the time-of-flight sequence of brain MRI
Time frame: 30-40 years of old
Cerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI
Time frame: 30-40 years of old
The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI
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
Time frame: 30-40 years of old
Arterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI
Time frame: 30-40 years of old
The level of VEGF-A (in pg/mL) measured from plasma blood samples
Time frame: 30-40 years of old
The level of sENG (in ng/mL) measured from plasma blood samples
Time frame: 30-40 years of old
The level of sFlt-1 (in pg/mL) measured from plasma blood samples
Time frame: 30-40 years of old
The level of total cholesterol (in mmol/L) measured from serum blood samples
Time frame: 30-40 years of old
The level of HDL (in mmol/L) measured from serum blood samples
Time frame: 30-40 years of old
The level of LDL (in mmol/L) measured from serum blood samples
Time frame: 30-40 years of old
The level of triglycerides (in mmol/L) measured from serum blood samples
Time frame: 30-40 years of old
The level of fasting glucose (in mmol/L) measured from whole blood samples
Time frame: 30-40 years of old
The level of fasting insulin (in pmol/L) measured from serum blood samples
Time frame: 30-40 years of old
The index calculated as fasting glucose (in mmol/L) x fasting insulin (in μIU/mL) ÷ 22.5
Time frame: 30-40 years of old
The level of CRP (in mmol/L) measured from serum blood samples
Time frame: 30-40 years of old
The level of sICAM-1 (in ng/mL) measured from serum blood samples
Time frame: 30-40 years of old
The level of sVCAM-1 (in ng/mL) measured from serum blood samples
Time frame: 30-40 years of old
Body weight measured in kg
Time frame: 30-40 years of old
Body height measured in m
Time frame: 30-40 years of old
Body weight divided by the square of height (in kg/m2)
Time frame: 30-40 years of old
Mid-arm circumference measured in cm
Time frame: 30-40 years of old
The ratio of waist circumference (in cm) to hip circumference (in cm)
Time frame: 30-40 years of old
Resting brachial blood pressure measurement (in mmHg)
Time frame: 30-40 years of old
Resting brachial blood pressure measurement (in mmHg)
Time frame: 30-40 years of old
The average arterial pressure from resting brachial blood pressure measurement (in mmHg)
Time frame: 30-40 years of old
The difference between systolic and diastolic blood pressure (in mmHg)
Time frame: 30-40 years of old
The frequency of the heart contractions per minute (in beats per minute or bpm)
Time frame: 30-40 years of old
The number and percentage of current smokers
Time frame: 30-40 years of old
Weekly alcoholic unit intake (in units per week)
Contact information is provided by the study sponsor or research team.
University of Oxford
Other
Cardiovascular Longitudinal the Avon Longitudinal Study of Parents and Children (ALSPAC) Research Investigations Following Hypertensive Pregnancy in Young Adulthood
Acronym: CLARITY
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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