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Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05683093
Acronym
CLARITY
Enrollment
200
Registered
2023-01-12
Start date
2022-11-17
Completion date
2027-01-31
Last updated
2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cerebrovascular Diseases, Hypertension, Hypertension in Pregnancy, Vascular Diseases, Young Adult

Keywords

Young Adult, Birth History, Hypertension in Pregnancy, Cardiovascular Risk, Exercise Capacity

Brief summary

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.

Detailed description

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.

Interventions

OTHERHistory of being born to hypertensive or normal pregnancy

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.

Sponsors

University of Bristol
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
30 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac right ventricular mass30-40 years of oldMagnetic resonance imaging (MRI) assessment of cardiac right ventricular mass indexed to body surface area (in g and g/m\^2)

Secondary

MeasureTime frameDescription
Cardiac left ventricular mass30-40 years of oldMRI assessment of cardiac left ventricular mass indexed to body surface area (in g and g/m\^2)
Cardiac right ventricular end-diastolic volume30-40 years of oldMRI assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\^2)
Cardiac right ventricular stroke volume30-40 years of oldMRI assessment of cardiac right ventricular stroke volume indexed to body surface area (in ml and ml/m\^2)
Cardiac left ventricular end-diastolic volume30-40 years of oldMRI assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\^2)
Cardiac left ventricular stroke volume30-40 years of oldMRI assessment of cardiac left ventricular stroke volume indexed to body surface area (in ml and ml/m\^2)
Cardiac right ventricular systolic function30-40 years of oldEchocardiography 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 %)
Carbon dioxide exchange kinetics across sub-maximal and peak exercise30-40 years of oldCardiopulmonary exercise test to measure respiratory exchange ratio (RER calculated as carbon dioxide production divided by oxygen consumption)
Cardiac right ventricular diastolic function30-40 years of oldEchocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)
Cardiac left ventricular diastolic function30-40 years of oldEchocardiography 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')
Morphology of the right ventricles30-40 years of oldMRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis
Morphology of the left ventricles30-40 years of oldMRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis
Aortic compliance30-40 years of oldAortic distensibility by MRI (in 10\^-3 mmHg\^-1) and aortic/central blood pressure by cuff measurement (in mmHg)
Intra-hepatic lipid content, steatohepatitis and hepatic fibrosis30-40 years of oldMRI assessment of the liver to quantify proton density fat fraction (in %) and fibro-inflammatory status from iron-corrected T1 (cT1 in ms)
Renal function30-40 years of oldMRI 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)
Oxygen uptake across sub-maximal and peak exercise30-40 years of oldCardiopulmonary exercise test to measure oxygen uptake (VO2 in ml/kg/min)
Retinal arteriolar structure30-40 years of oldCentral retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging
Retinal venular structure30-40 years of oldCentral retinal venular equivalent (CRVE in μm) measured using retinal imaging
Retinal arteriolar-to-venular diameter ratio (AVR)30-40 years of oldThe ratio of average retinal arteriolar diameter (CRAE in μm) and average retinal venous diameter (CRVE in μm) measured using retinal imaging
Ear microvascular structure30-40 years of oldSuperior crus of anti-helix earlobe vascular caliber (in μm) measured using ear vascular imaging
Lung function30-40 years of oldThe 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
Objective measure of physical activity30-40 years of oldThe amount of moderate to vigorous physical activity (in h/week) and vigorous physical activity (in h/week) measured using wrist worn accelerometer
Total white matter volume30-40 years of oldTotal white matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI
Total grey matter volume30-40 years of oldTotal grey matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI
Subcortical brain volume of thalamus30-40 years of oldSubcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI
Subcortical brain volume of hippocampus30-40 years of oldSubcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI
White matter hyperintensities volume30-40 years of oldTotal volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI
White matter hyperintensities count30-40 years of oldThe number of white matter hyperintensities on T2-weighted sequence of brain MRI
Cerebral vessel lumen diameter30-40 years of oldCerebral vessel lumen diameter (in μm) assessed on the time-of-flight sequence of brain MRI
Cerebral vessel density30-40 years of oldCerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI
Cerebral vessel tortuosity30-40 years of oldThe ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI
Whole brain grey matter perfusion or cerebral blood flow (CBF)30-40 years of oldWhole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain MRI
Arterial cerebral blood volume fraction30-40 years of oldArterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI
Circulating vascular endothelial growth factor A (VEGF-A) as an angiogenic marker30-40 years of oldThe level of VEGF-A (in pg/mL) measured from plasma blood samples
Circulating soluble endoglin (sENG) as an angiogenic marker30-40 years of oldThe level of sENG (in ng/mL) measured from plasma blood samples
Circulating soluble fms-like tyrosine kinase-1 (sFlt-1) as an antiangiogenic marker30-40 years of oldThe level of sFlt-1 (in pg/mL) measured from plasma blood samples
Circulating total cholesterol as a metabolic marker30-40 years of oldThe level of total cholesterol (in mmol/L) measured from serum blood samples
Circulating high-density lipoprotein as a metabolic marker30-40 years of oldThe level of HDL (in mmol/L) measured from serum blood samples
Circulating low-density lipoprotein as a metabolic marker30-40 years of oldThe level of LDL (in mmol/L) measured from serum blood samples
Circulating triglycerides as a metabolic marker30-40 years of oldThe level of triglycerides (in mmol/L) measured from serum blood samples
Circulating fasting glucose concentration as a metabolic marker30-40 years of oldThe level of fasting glucose (in mmol/L) measured from whole blood samples
Circulating fasting insulin concentration as a metabolic marker30-40 years of oldThe level of fasting insulin (in pmol/L) measured from serum blood samples
Insulin resistance index (HOMA-IR) as a metabolic marker30-40 years of oldThe index calculated as fasting glucose (in mmol/L) x fasting insulin (in μIU/mL) ÷ 22.5
Circulating C-reactive protein (CRP) as an inflammatory marker30-40 years of oldThe level of CRP (in mmol/L) measured from serum blood samples
Circulating soluble intercellular adhesion molecule-1 (sICAM-1) as an inflammatory marker30-40 years of oldThe level of sICAM-1 (in ng/mL) measured from serum blood samples
Circulating soluble vascular cell adhesion molecule-1 (sVCAM-1) as an inflammatory marker30-40 years of oldThe level of sVCAM-1 (in ng/mL) measured from serum blood samples
Body weight30-40 years of oldBody weight measured in kg
Body height30-40 years of oldBody height measured in m
Body mass index30-40 years of oldBody weight divided by the square of height (in kg/m2)
Mid-arm circumference30-40 years of oldMid-arm circumference measured in cm
Waist-to-hip ratio30-40 years of oldThe ratio of waist circumference (in cm) to hip circumference (in cm)
Cardiac left ventricular systolic function30-40 years of oldEchocardiography and MRI assessment of left ventricular systolic function: left ventricular ejection fraction (in %)
Diastolic blood pressure30-40 years of oldResting brachial blood pressure measurement (in mmHg)
Mean arterial pressure30-40 years of oldThe average arterial pressure from resting brachial blood pressure measurement (in mmHg)
Pulse pressure30-40 years of oldThe difference between systolic and diastolic blood pressure (in mmHg)
Heart rate30-40 years of oldThe frequency of the heart contractions per minute (in beats per minute or bpm)
Smoking status30-40 years of oldThe number and percentage of current smokers
Alcohol consumption30-40 years of oldWeekly alcoholic unit intake (in units per week)
Systolic blood pressure30-40 years of oldResting brachial blood pressure measurement (in mmHg)

Countries

United Kingdom

Contacts

Primary ContactKatie Suriano
clarity@cardiov.ox.ac.uk01865 226845

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026