Clinical trial NCT05683093: Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood
Official title: Cardiovascular Longitudinal the Avon Longitudinal Study of Parents and Children (ALSPAC) Research Investigations Following Hypertensive Pregnancy in Young Adulthood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Young Adult
Hypertension in Pregnancy
Hypertension
Cardiovascular Diseases
Cerebrovascular Diseases
Vascular Diseases
Keywords: Young Adult
Birth History
Hypertension in Pregnancy
Cardiovascular Risk
Exercise Capacity
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: University of Bristol
First posted: 2023-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac right ventricular mass
timeFrame: 30-40 years of old
Secondary outcomes:
measure: Cardiac left ventricular mass
timeFrame: 30-40 years of old
measure: Cardiac right ventricular end-diastolic volume
timeFrame: 30-40 years of old
measure: Cardiac right ventricular stroke volume
timeFrame: 30-40 years of old
measure: Cardiac left ventricular end-diastolic volume
timeFrame: 30-40 years of old
measure: Cardiac left ventricular stroke volume
timeFrame: 30-40 years of old
measure: Cardiac right ventricular systolic function
timeFrame: 30-40 years of old
measure: Cardiac left ventricular systolic function
timeFrame: 30-40 years of old
measure: Cardiac right ventricular diastolic function
timeFrame: 30-40 years of old
measure: Cardiac left ventricular diastolic function
timeFrame: 30-40 years of old
measure: Morphology of the right ventricles
timeFrame: 30-40 years of old
measure: Morphology of the left ventricles
timeFrame: 30-40 years of old
measure: Aortic compliance
timeFrame: 30-40 years of old
measure: Intra-hepatic lipid content, steatohepatitis and hepatic fibrosis
timeFrame: 30-40 years of old
measure: Renal function
timeFrame: 30-40 years of old
measure: Oxygen uptake across sub-maximal and peak exercise
timeFrame: 30-40 years of old
measure: Carbon dioxide exchange kinetics across sub-maximal and peak exercise
timeFrame: 30-40 years of old
measure: Retinal arteriolar structure
timeFrame: 30-40 years of old
measure: Retinal venular structure
timeFrame: 30-40 years of old
measure: Retinal arteriolar-to-venular diameter ratio (AVR)
timeFrame: 30-40 years of old
measure: Ear microvascular structure
timeFrame: 30-40 years of old
measure: Lung function
timeFrame: 30-40 years of old
measure: Objective measure of physical activity
timeFrame: 30-40 years of old
measure: Total white matter volume
timeFrame: 30-40 years of old
measure: Total grey matter volume
timeFrame: 30-40 years of old
measure: Subcortical brain volume of thalamus
timeFrame: 30-40 years of old
measure: Subcortical brain volume of hippocampus
timeFrame: 30-40 years of old
measure: White matter hyperintensities volume
timeFrame: 30-40 years of old
measure: White matter hyperintensities count
timeFrame: 30-40 years of old
measure: Cerebral vessel lumen diameter
timeFrame: 30-40 years of old
measure: Cerebral vessel density
timeFrame: 30-40 years of old
measure: Cerebral vessel tortuosity
timeFrame: 30-40 years of old
measure: Whole brain grey matter perfusion or cerebral blood flow (CBF)
timeFrame: 30-40 years of old
measure: Arterial cerebral blood volume fraction
timeFrame: 30-40 years of old
measure: Circulating vascular endothelial growth factor A (VEGF-A) as an angiogenic marker
timeFrame: 30-40 years of old
measure: Circulating soluble endoglin (sENG) as an angiogenic marker
timeFrame: 30-40 years of old
measure: Circulating soluble fms-like tyrosine kinase-1 (sFlt-1) as an antiangiogenic marker
timeFrame: 30-40 years of old
measure: Circulating total cholesterol as a metabolic marker
timeFrame: 30-40 years of old
measure: Circulating high-density lipoprotein as a metabolic marker
timeFrame: 30-40 years of old
measure: Circulating low-density lipoprotein as a metabolic marker
timeFrame: 30-40 years of old
measure: Circulating triglycerides as a metabolic marker
timeFrame: 30-40 years of old
measure: Circulating fasting glucose concentration as a metabolic marker
timeFrame: 30-40 years of old
measure: Circulating fasting insulin concentration as a metabolic marker
timeFrame: 30-40 years of old
measure: Insulin resistance index (HOMA-IR) as a metabolic marker
timeFrame: 30-40 years of old
measure: Circulating C-reactive protein (CRP) as an inflammatory marker
timeFrame: 30-40 years of old
measure: Circulating soluble intercellular adhesion molecule-1 (sICAM-1) as an inflammatory marker
timeFrame: 30-40 years of old
measure: Circulating soluble vascular cell adhesion molecule-1 (sVCAM-1) as an inflammatory marker
timeFrame: 30-40 years of old
measure: Body weight
timeFrame: 30-40 years of old
measure: Body height
timeFrame: 30-40 years of old
measure: Body mass index
timeFrame: 30-40 years of old
measure: Mid-arm circumference
timeFrame: 30-40 years of old
measure: Waist-to-hip ratio
timeFrame: 30-40 years of old
measure: Systolic blood pressure
timeFrame: 30-40 years of old
measure: Diastolic blood pressure
timeFrame: 30-40 years of old
measure: Mean arterial pressure
timeFrame: 30-40 years of old
measure: Pulse pressure
timeFrame: 30-40 years of old
measure: Heart rate
timeFrame: 30-40 years of old
measure: Smoking status
timeFrame: 30-40 years of old
measure: Alcohol consumption
timeFrame: 30-40 years of old
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
affiliation: Cardiovascular Clinical Research Facility
name: Adam J Lewandowski
role: PRINCIPAL_INVESTIGATOR
References: