Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood (CLARITY)

January 5, 2023 updated by: University of Oxford

Cardiovascular Longitudinal the Avon Longitudinal Study of Parents and Children (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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
30-40 years of old

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
30-40 years of old
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)
30-40 years of old
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)
30-40 years of old
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)
30-40 years of old
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)
30-40 years of old
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 %)
30-40 years of old
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 %)
30-40 years of old
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)
30-40 years of old
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')
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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)
30-40 years of old
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)
30-40 years of old
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)
30-40 years of old
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)
30-40 years of old
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)
30-40 years of old
Retinal arteriolar structure
Time Frame: 30-40 years of old
Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging
30-40 years of old
Retinal venular structure
Time Frame: 30-40 years of old
Central retinal venular equivalent (CRVE in μm) measured using retinal imaging
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
White matter hyperintensities count
Time Frame: 30-40 years of old
The number of white matter hyperintensities on T2-weighted sequence of brain MRI
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
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
30-40 years of old
Body weight
Time Frame: 30-40 years of old
Body weight measured in kg
30-40 years of old
Body height
Time Frame: 30-40 years of old
Body height measured in m
30-40 years of old
Body mass index
Time Frame: 30-40 years of old
Body weight divided by the square of height (in kg/m2)
30-40 years of old
Mid-arm circumference
Time Frame: 30-40 years of old
Mid-arm circumference measured in cm
30-40 years of old
Waist-to-hip ratio
Time Frame: 30-40 years of old
The ratio of waist circumference (in cm) to hip circumference (in cm)
30-40 years of old
Systolic blood pressure
Time Frame: 30-40 years of old
Resting brachial blood pressure measurement (in mmHg)
30-40 years of old
Diastolic blood pressure
Time Frame: 30-40 years of old
Resting brachial blood pressure measurement (in mmHg)
30-40 years of old
Mean arterial pressure
Time Frame: 30-40 years of old
The average arterial pressure from resting brachial blood pressure measurement (in mmHg)
30-40 years of old
Pulse pressure
Time Frame: 30-40 years of old
The difference between systolic and diastolic blood pressure (in mmHg)
30-40 years of old
Heart rate
Time Frame: 30-40 years of old
The frequency of the heart contractions per minute (in beats per minute or bpm)
30-40 years of old
Smoking status
Time Frame: 30-40 years of old
The number and percentage of current smokers
30-40 years of old
Alcohol consumption
Time Frame: 30-40 years of old
Weekly alcoholic unit intake (in units per week)
30-40 years of old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bristol

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam J Lewandowski, Cardiovascular Clinical Research Facility

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/WA/0227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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