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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06187012
Other study ID # 22/LO/0781
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 23, 2023
Est. completion date November 1, 2042

Study information

Verified date December 2023
Source University of Oxford
Contact Katie Suriano
Phone 01865226845
Email helpful@cardiov.ox.ac.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 1, 2042
Est. primary completion date November 1, 2027
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Other:
Hypertensive pregnancy
Participants will attend one visit lasting approximately 3-4 hours on a single day or split over multiple visits to complete all measures. Participants will first be asked to provide written informed consent for the study. Participants' anthropometric measures (waist-to-hip ratio, height and weight, hip and waist circumference and left arm circumference and resting blood pressures will then be taken. After this, the participants will undergo cardiopulmonary exercise testing, followed by magnetic resonance imaging, echocardiography, retinal imaging and vascular imaging of the ear. The study visit will conclude with participants being provided with a wrist-worn physical activity monitor to wear for 7-9 days following the visit. These monitors will provide objective measures of physical activity while people go about their normal activities.

Locations

Country Name City State
United Kingdom University of Oxford Department of Cardiovascular Medicine Oxford

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac right ventricular mass Magnetic resonance imaging assessment of cardiac right ventricular mass indexed to body surface area (g/m^2). 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.
Secondary Cardiac left ventricular mass Magnetic resonance imaging assessment of cardiac left ventricular mass indexed to body surface area (g/m^2). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac right ventricular end-diastolic volume Magnetic resonance imaging assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (ml/m^2) Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac right ventricular stroke volume. Magnetic resonance imaging assessment of cardiac right ventricular stroke volume indexed to body surface area (ml/m^2). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac left-ventricular end-diastolic volume. Magnetic resonance imaging assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (ml/m^2). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac left ventricular stroke volume Magnetic resonance imaging assessment of cardiac left ventricular stroke volume indexed to body surface area (ml/m^2). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac right ventricular systolic function Echocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (cm). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac right ventricular ejection fraction Magnetic resonance imaging assessment of right ventricular ejection fraction measured by cardiac magnetic resonance imaging (%). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac left ventricular systolic function Echocardiography assessment of 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
Secondary Cardiac left ventricular ejection fraction Magnetic resonance imaging assessment of 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
Secondary Cardiac right ventricular diastolic function Echocardiography assessment of right ventricular doppler early/late diastolic tricuspid inflow velocity ratio (E/A) Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac left ventricular diastolic function Echocardiography assessment of left ventricular doppler early/late diastolic mitral inflow velocity ratio (E/A). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cardiac left ventricular diastolic function Echocardiography assessment of left ventricular early doppler inflow velocity/peak early diastolic tissue velocity rate (E/e'). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Morphology of the right ventricles Magnetic resonance imaging assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Morphology of the left ventricles Magnetic resonance imaging assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Aortic distensibility Aortic distensibility by magnetic resonance imaging (10^-3 mmHg-1). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Aortic compliance Aortic/central blood pressure by cuff measurement (mmHg). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Intra-hepatic liquid content and steatohepatitis Magnetic resonance imaging assessment of the liver to quantify proton density fat fraction (%). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Hepatic fibrosis Magnetic resonance imaging assessment of the liver to quantify fibro-inflammatory status from iron corrected T1 (cT1 in ms) Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Renal volumes Magnetic resonance imaging assessment of renal volumes (ml/m^2). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Renal fibro-inflammatory status Magnetic resonance imaging assessment of fibro-inflammatory status from T1 (ms) Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Renal blood perfusion Magnetic resonance imaging assessment of surrogate measures of blood perfusion from T2* (in ms). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Oxygen uptake across submaximal exercise Cardiopulmonary exercise test to measure oxygen uptake (ml/kg/min). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Carbon dioxide exchange kinetics across submaximal exercise Cardiopulmonary exercise test to measure respiratory exchange ratio (RER) calculated as carbon dioxide production divided by oxygen consumption. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Retinal arteriolar structure Central retinal arteriolar equivalent (CRAE) in micrometres measured using retinal imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Retinal venular structure Central retinal venular equivalent (micrometres) measured using retinal imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Retinal arteriolar-to venule diameter ratio (AVR) The ratio of average retinal arteriolar diameter and average retinal venous diameter (micrometres). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Ear microvascular structure. Superior crus of anti-helix earlobe vascular calibre (micrometres) measured using ear vascular imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Lung function The ratio of FEV1 to FVC (FEV1/FVC) measured using spirometry. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Lung capacity The forced vital capacity (FVC in L) measured using spirometry. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Lung volume The forced expiratory volume in one second (FEV1 in L) measured using spirometry. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Objective measure of vigorous physical activity. The amount of vigorous physical activity (h/week) measured using wrist worn accelerometer. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Objective measure of moderate to vigorous physical activity. The amount of moderate to vigorous physical activity (h/week) measured using wrist worn accelerometer. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Total white matter volume Total white matter volumes (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Total grey matter volume Total grey matter volumes (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Subcortical brain volume of thalamus Subcortical brain volume of thalamus (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Subcortical brain volume of hippocampus Subcortical brain volume of hippocampus (mm3) assessed on T1-weighted sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary White matter hyperintensities volume Total volume of white matter hyperintensities (mm3) assessed on T2-weighted sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary White matter hyperintensities count Total number of white matter hyperintensities on T2-weighted sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cerebral vessel lumen diameter Cerebral vessel lumen diameter (micrometres) assessed on the time-of-flight sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cerebral vessel tortuosity The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Cerebral vessel density Cerebral vessel density (mm3) assessed on the time-of-flight sequence of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Whole brain grey matter perfusion or cerebral blood flow (CBF) Whole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Arterial cerebral blood volume fraction Arterial cerebral blood volume fraction (%) assessed on arterial spin labelling on brain magnetic resonance imaging. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating vascular endothelial growth factor A as an angiogenic marker The level of circulating vascular endothelial growth factor A (pg/mL) measured from plasma blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating soluble endoglin as an angiogenic marker. The level of circulating soluble endoglin (ng/mL) measured from plasma blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating soluble fms-like tyrosine kinase-1 as an angiogenic marker. The level of circulating soluble fms-like tyrosine kinase-1 measured from plasma blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating total cholesterol as a metabolic marker The level of total cholesterol (mmol/L) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating high-density lipoprotein as a metabolic marker The level of circulating high-density lipoprotein (mmol/L) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating low-density lipoprotein as a metabolic marker The level of circulating low-density lipoprotein (mmol/L) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating triglycerides as a metabolic marker The level of circulating triglycerides (mmol/L) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating fasting glucose concentration as a metabolic marker The level of fasting glucose (mmol/L) measured from whole blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating fasting insulin concentration as a metabolic marker The level of fasting insulin (pmol/L) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Insulin resistance index as a metabolic marker The index calculated as fasting glucose (mmol/L) x fasting insulin (ulU/mL)/22.5. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating C-reactive protein as an inflammatory marker. The level of circulating C-reactive protein (mmol/L) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating soluble intercellular adhesion molecule-1 (slCAM-1) as an inflammatory marker The level of sICAM-1 (ng/mL) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Circulating soluble vascular adhesion molecule-1 (sVCAM-1) as an inflammatory marker The level of sVCAM-1 (ng/mL) measured from serum blood samples. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Body weight Body weight (kg) Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Body height Body height (m). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Body mass index (BMI) Body weight divided by the square of height (kg/m2). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Mid-arm circumference Mid-arm circumference (cm). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Waist-to-hip ratio The ratio of waist circumference (cm) to hip circumference (cm). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Systolic blood pressure Resting brachial blood pressure measurement (mmHg). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Diastolic blood pressure Resting brachial blood pressure measurement (mmHg). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Mean arterial pressure. The average arterial pressure from resting brachial blood pressure measurement (mmHg). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Pulse pressure The difference between systolic and diastolic blood pressure (mmHg). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Heart rate The frequency of the heart contractions per minute (bpm). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Smoking status The number and percentage of current smokers. Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
Secondary Alcohol consumption Weekly alcoholic unit intake (units per week). Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy
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