Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)

University of Oxford1 site in 1 country200 target enrollmentMarch 23, 2023

ConditionsHypertension Cardiovascular Diseases Cerebrovascular Disorders Vascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: University of Oxford
Enrollment: 200
Locations: 1
Primary Endpoint: Cardiac right ventricular mass
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to understand more about why women who have had hypertensive pregnancies may be at increased risk of high blood pressure and why these women are often at increased risk of heart and blood vessel disease later in life.

Detailed Description

Women who experience high blood pressure during pregnancy are at increased risk of developing cardiac and vascular diseases later in life. They show changes in their heart, brain, and blood vessels long before they develop high blood pressure. The investigators therefore think that these changes develop slowly over the course of the life of the woman and establish their risk of later disease. Through better understanding of the pattern of changes across multiple parts of the body over extended periods of time, the investigators aim to identify how advanced the underlying disease is for an individual and how the disease is likely to develop over the next few years. By comparing the rate of change across different parts of the body, the investigators can examine how one area affects another. Data including images of the heart, brain and blood vessels will be acquired in women 10 to 25 years after their pregnancy. The initial analysis will focus on assessing differences between women who have had a normotensive pregnancy and those who have had a hypertensive pregnancy, both at a single timepoint and in changes within individuals over time. This dataset will then be used in conjunction with previously acquired data in women who have experienced a hypertensive pregnancy to find out how patterns emerge across the whole body. The investigators will subsequently combine information from different measures at the same time and use the machine learning models to learn the patterns of change that occur as a person progresses from a healthy to a diseased state. This will allow the researchers to identify patterns of hypertensive disease development and it may open doors to better interventions and therapies tailored towards individuals.

Registry

clinicaltrials.gov

Start Date

March 23, 2023

End Date

November 1, 2042

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria
•Participant is willing and able to give informed consent for participation in the study
•Female who had a pregnancy 10 to 25 years prior
•Able (in the investigator's opinion) and willing to comply with all study requirements.
•Adequate understanding of verbal and written English

Exclusion Criteria

•The participant may not enter the study if ANY of the following apply:
•Over 10 weeks pregnant during the course of the study
•Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status
•Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study
•For exclusion of MRI component only:
•Unsuitable for MRI based on the responses to the MRI screening form. The participant may still be included in other parts of the study.

Outcomes

Primary Outcomes

Cardiac right ventricular mass

Time Frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy. Index pregnancy is defined as the pregnancy which we first collected data from.

Magnetic resonance imaging assessment of cardiac right ventricular mass indexed to body surface area (g/m\^2).

Secondary Outcomes

Cardiac right ventricular end-diastolic volume(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac left ventricular systolic function(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac left ventricular ejection fraction(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Aortic distensibility(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Renal fibro-inflammatory status(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Retinal arteriolar-to venule diameter ratio (AVR)(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cerebral vessel lumen diameter(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac right ventricular stroke volume.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac left ventricular mass(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac left-ventricular end-diastolic volume.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac left ventricular stroke volume(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Morphology of the right ventricles(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Morphology of the left ventricles(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Carbon dioxide exchange kinetics across submaximal exercise(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Retinal venular structure(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Ear microvascular structure.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Lung capacity(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Objective measure of vigorous physical activity.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Total white matter volume(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
White matter hyperintensities volume(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating total cholesterol as a metabolic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating high-density lipoprotein as a metabolic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac right ventricular systolic function(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac right ventricular ejection fraction(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac right ventricular diastolic function(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cardiac left ventricular diastolic function(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Aortic compliance(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Intra-hepatic liquid content and steatohepatitis(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Hepatic fibrosis(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
White matter hyperintensities count(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating low-density lipoprotein as a metabolic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating soluble intercellular adhesion molecule-1 (slCAM-1) as an inflammatory marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating soluble vascular adhesion molecule-1 (sVCAM-1) as an inflammatory marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Renal volumes(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Renal blood perfusion(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Oxygen uptake across submaximal exercise(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Retinal arteriolar structure(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Objective measure of moderate to vigorous physical activity.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Total grey matter volume(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Subcortical brain volume of hippocampus(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cerebral vessel tortuosity(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Whole brain grey matter perfusion or cerebral blood flow (CBF)(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Arterial cerebral blood volume fraction(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating vascular endothelial growth factor A as an angiogenic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating soluble fms-like tyrosine kinase-1 as an angiogenic marker.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating fasting glucose concentration as a metabolic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Body height(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Diastolic blood pressure(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Heart rate(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Lung function(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Lung volume(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Subcortical brain volume of thalamus(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Cerebral vessel density(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating soluble endoglin as an angiogenic marker.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating triglycerides as a metabolic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating fasting insulin concentration as a metabolic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Insulin resistance index as a metabolic marker(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Body mass index (BMI)(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Systolic blood pressure(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Mean arterial pressure.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Pulse pressure(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Smoking status(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Circulating C-reactive protein as an inflammatory marker.(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Waist-to-hip ratio(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Body weight(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Mid-arm circumference(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)
Alcohol consumption(Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy)