Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05683093
Status:
RECRUITING
Last Update Posted:
2023-01-12
First Post:
2022-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac right ventricular mass', 'timeFrame': '30-40 years of old', 'description': 'Magnetic resonance imaging (MRI) assessment of cardiac right ventricular mass indexed to body surface area (in g and g/m\\^2)'}], 'secondaryOutcomes': [{'measure': 'Cardiac left ventricular mass', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of cardiac left ventricular mass indexed to body surface area (in g and g/m\\^2)'}, {'measure': 'Cardiac right ventricular end-diastolic volume', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\\^2)'}, {'measure': 'Cardiac right ventricular stroke volume', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of cardiac right ventricular stroke volume indexed to body surface area (in ml and ml/m\\^2)'}, {'measure': 'Cardiac left ventricular end-diastolic volume', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\\^2)'}, {'measure': 'Cardiac left ventricular stroke volume', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of cardiac left ventricular stroke volume indexed to body surface area (in ml and ml/m\\^2)'}, {'measure': 'Cardiac right ventricular systolic function', 'timeFrame': '30-40 years of old', 'description': '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 %)'}, {'measure': 'Cardiac left ventricular systolic function', 'timeFrame': '30-40 years of old', 'description': 'Echocardiography and MRI assessment of left ventricular systolic function: left ventricular ejection fraction (in %)'}, {'measure': 'Cardiac right ventricular diastolic function', 'timeFrame': '30-40 years of old', 'description': 'Echocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)'}, {'measure': 'Cardiac left ventricular diastolic function', 'timeFrame': '30-40 years of old', 'description': "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')"}, {'measure': 'Morphology of the right ventricles', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis'}, {'measure': 'Morphology of the left ventricles', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis'}, {'measure': 'Aortic compliance', 'timeFrame': '30-40 years of old', 'description': 'Aortic distensibility by MRI (in 10\\^-3 mmHg\\^-1) and aortic/central blood pressure by cuff measurement (in mmHg)'}, {'measure': 'Intra-hepatic lipid content, steatohepatitis and hepatic fibrosis', 'timeFrame': '30-40 years of old', 'description': 'MRI assessment of the liver to quantify proton density fat fraction (in %) and fibro-inflammatory status from iron-corrected T1 (cT1 in ms)'}, {'measure': 'Renal function', 'timeFrame': '30-40 years of old', 'description': '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)'}, {'measure': 'Oxygen uptake across sub-maximal and peak exercise', 'timeFrame': '30-40 years of old', 'description': 'Cardiopulmonary exercise test to measure oxygen uptake (VO2 in ml/kg/min)'}, {'measure': 'Carbon dioxide exchange kinetics across sub-maximal and peak exercise', 'timeFrame': '30-40 years of old', 'description': 'Cardiopulmonary exercise test to measure respiratory exchange ratio (RER calculated as carbon dioxide production divided by oxygen consumption)'}, {'measure': 'Retinal arteriolar structure', 'timeFrame': '30-40 years of old', 'description': 'Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging'}, {'measure': 'Retinal venular structure', 'timeFrame': '30-40 years of old', 'description': 'Central retinal venular equivalent (CRVE in μm) measured using retinal imaging'}, {'measure': 'Retinal arteriolar-to-venular diameter ratio (AVR)', 'timeFrame': '30-40 years of old', 'description': 'The ratio of average retinal arteriolar diameter (CRAE in μm) and average retinal venous diameter (CRVE in μm) measured using retinal imaging'}, {'measure': 'Ear microvascular structure', 'timeFrame': '30-40 years of old', 'description': 'Superior crus of anti-helix earlobe vascular caliber (in μm) measured using ear vascular imaging'}, {'measure': 'Lung function', 'timeFrame': '30-40 years of old', 'description': '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'}, {'measure': 'Objective measure of physical activity', 'timeFrame': '30-40 years of old', 'description': 'The amount of moderate to vigorous physical activity (in h/week) and vigorous physical activity (in h/week) measured using wrist worn accelerometer'}, {'measure': 'Total white matter volume', 'timeFrame': '30-40 years of old', 'description': 'Total white matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI'}, {'measure': 'Total grey matter volume', 'timeFrame': '30-40 years of old', 'description': 'Total grey matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI'}, {'measure': 'Subcortical brain volume of thalamus', 'timeFrame': '30-40 years of old', 'description': 'Subcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI'}, {'measure': 'Subcortical brain volume of hippocampus', 'timeFrame': '30-40 years of old', 'description': 'Subcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI'}, {'measure': 'White matter hyperintensities volume', 'timeFrame': '30-40 years of old', 'description': 'Total volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI'}, {'measure': 'White matter hyperintensities count', 'timeFrame': '30-40 years of old', 'description': 'The number of white matter hyperintensities on T2-weighted sequence of brain MRI'}, {'measure': 'Cerebral vessel lumen diameter', 'timeFrame': '30-40 years of old', 'description': 'Cerebral vessel lumen diameter (in μm) assessed on the time-of-flight sequence of brain MRI'}, {'measure': 'Cerebral vessel density', 'timeFrame': '30-40 years of old', 'description': 'Cerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI'}, {'measure': 'Cerebral vessel tortuosity', 'timeFrame': '30-40 years of old', 'description': 'The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI'}, {'measure': 'Whole brain grey matter perfusion or cerebral blood flow (CBF)', 'timeFrame': '30-40 years of old', 'description': 'Whole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain MRI'}, {'measure': 'Arterial cerebral blood volume fraction', 'timeFrame': '30-40 years of old', 'description': 'Arterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI'}, {'measure': 'Circulating vascular endothelial growth factor A (VEGF-A) as an angiogenic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of VEGF-A (in pg/mL) measured from plasma blood samples'}, {'measure': 'Circulating soluble endoglin (sENG) as an angiogenic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of sENG (in ng/mL) measured from plasma blood samples'}, {'measure': 'Circulating soluble fms-like tyrosine kinase-1 (sFlt-1) as an antiangiogenic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of sFlt-1 (in pg/mL) measured from plasma blood samples'}, {'measure': 'Circulating total cholesterol as a metabolic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of total cholesterol (in mmol/L) measured from serum blood samples'}, {'measure': 'Circulating high-density lipoprotein as a metabolic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of HDL (in mmol/L) measured from serum blood samples'}, {'measure': 'Circulating low-density lipoprotein as a metabolic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of LDL (in mmol/L) measured from serum blood samples'}, {'measure': 'Circulating triglycerides as a metabolic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of triglycerides (in mmol/L) measured from serum blood samples'}, {'measure': 'Circulating fasting glucose concentration as a metabolic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of fasting glucose (in mmol/L) measured from whole blood samples'}, {'measure': 'Circulating fasting insulin concentration as a metabolic marker', 'timeFrame': '30-40 years of old', 'description': 'The level of fasting insulin (in pmol/L) measured from serum blood samples'}, {'measure': 'Insulin resistance index (HOMA-IR) as a metabolic marker', 'timeFrame': '30-40 years of old', 'description': 'The index calculated as fasting glucose (in mmol/L) x fasting insulin (in μIU/mL) ÷ 22.5'}, {'measure': 'Circulating C-reactive protein (CRP) as an inflammatory marker', 'timeFrame': '30-40 years of old', 'description': 'The level of CRP (in mmol/L) measured from serum blood samples'}, {'measure': 'Circulating soluble intercellular adhesion molecule-1 (sICAM-1) as an inflammatory marker', 'timeFrame': '30-40 years of old', 'description': 'The level of sICAM-1 (in ng/mL) measured from serum blood samples'}, {'measure': 'Circulating soluble vascular cell adhesion molecule-1 (sVCAM-1) as an inflammatory marker', 'timeFrame': '30-40 years of old', 'description': 'The level of sVCAM-1 (in ng/mL) measured from serum blood samples'}, {'measure': 'Body weight', 'timeFrame': '30-40 years of old', 'description': 'Body weight measured in kg'}, {'measure': 'Body height', 'timeFrame': '30-40 years of old', 'description': 'Body height measured in m'}, {'measure': 'Body mass index', 'timeFrame': '30-40 years of old', 'description': 'Body weight divided by the square of height (in kg/m2)'}, {'measure': 'Mid-arm circumference', 'timeFrame': '30-40 years of old', 'description': 'Mid-arm circumference measured in cm'}, {'measure': 'Waist-to-hip ratio', 'timeFrame': '30-40 years of old', 'description': 'The ratio of waist circumference (in cm) to hip circumference (in cm)'}, {'measure': 'Systolic blood pressure', 'timeFrame': '30-40 years of old', 'description': 'Resting brachial blood pressure measurement (in mmHg)'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '30-40 years of old', 'description': 'Resting brachial blood pressure measurement (in mmHg)'}, {'measure': 'Mean arterial pressure', 'timeFrame': '30-40 years of old', 'description': 'The average arterial pressure from resting brachial blood pressure measurement (in mmHg)'}, {'measure': 'Pulse pressure', 'timeFrame': '30-40 years of old', 'description': 'The difference between systolic and diastolic blood pressure (in mmHg)'}, {'measure': 'Heart rate', 'timeFrame': '30-40 years of old', 'description': 'The frequency of the heart contractions per minute (in beats per minute or bpm)'}, {'measure': 'Smoking status', 'timeFrame': '30-40 years of old', 'description': 'The number and percentage of current smokers'}, {'measure': 'Alcohol consumption', 'timeFrame': '30-40 years of old', 'description': 'Weekly alcoholic unit intake (in units per week)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young Adult', 'Birth History', 'Hypertension in Pregnancy', 'Cardiovascular Risk', 'Exercise Capacity'], 'conditions': ['Young Adult', 'Hypertension in Pregnancy', 'Hypertension', 'Cardiovascular Diseases', 'Cerebrovascular Diseases', 'Vascular Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Of the 200 young adults followed up from the ALSPAC study, 100 will have been born to a hypertensive pregnancy and 100 following an uncomplicated pregnancy. At time of follow-up, they will be 30 to 40 years of age. At the 25-year follow-up in Bristol, there were 610 individuals born to hypertensive pregnancies.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study\n* Male or female, aged 30 to 40 years at time of enrolment\n* Participant previously took part in the ALSPAC study\n* Able (in the investigator's opinion) and willing to comply with all study requirements\n* Adequate understanding of verbal and written English\n\nExclusion Criteria:\n\n* Pregnant or lactating when they are due to attend for study visit 1\n* Less than six months postpartum\n* Planning to donate blood within two weeks prior to study visit 1\n* Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study\n* Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status\n\nFor exclusion of MRI component only:\n\n* Unsuitable for MRI based on participant screening; the participant may still be included in other parts of the study"}, 'identificationModule': {'nctId': 'NCT05683093', 'acronym': 'CLARITY', 'briefTitle': 'Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Cardiovascular Longitudinal the Avon Longitudinal Study of Parents and Children (ALSPAC) Research Investigations Following Hypertensive Pregnancy in Young Adulthood', 'orgStudyIdInfo': {'id': '22/WA/0227'}}, 'armsInterventionsModule': {'interventions': [{'name': 'History of being born to hypertensive or normal pregnancy', 'type': 'OTHER', 'description': '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.\n\nParticipants 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Katie Suriano', 'role': 'CONTACT', 'email': 'clarity@cardiov.ox.ac.uk', 'phone': '01865 226845'}], 'facility': 'University of Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'Katie Suriano', 'role': 'CONTACT', 'email': 'clarity@cardiov.ox.ac.uk', 'phone': '01865 226845'}], 'overallOfficials': [{'name': 'Adam J Lewandowski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Clinical Research Facility'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bristol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}