Clinical trial NCT06187012: Hypertension Explored in Long-term Postpartum Follow-up in Later Life
Official title: Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Cardiovascular Diseases
Cerebrovascular Disorders
Vascular Diseases
Keywords: Hypertensive pregnancy
Older adults
Pre-eclampsia
Gestational hypertension
Cardiovascular risk
Disease progression
Longitudinal
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will study a group of 200 women at 10 to 25 years postpartum to extend data coverage over time and to ensure a broad representation of hypertensive disease state during mid-life in women. This will be achieved by a follow-up of participants from a previous study called Preeclampsia Vascular Study (PVS) (08/H0604/127). These women were originally seen at 5 to 15 years post-index hypertensive or normotensive pregnancy. If required, the investigators will restart their identification and recruitment methods, previously used in PVS, based on obstetric records to identify, and recruit additional women who had pregnancies 10 to 25 years prior, to ensure that the sample size is reached. All participants will undergo a standardised imaging protocol as described in the general 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.

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.

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