Hypertension Explored in Long-term Postpartum Follow-up in Later Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypertensive pregnancy.
- Who it may be relevant to
- Registry conditions: Hypertension, Cardiovascular Diseases, Cerebrovascular Disorders, Vascular Diseases. Basic parameters: 30 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)
Overview
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.
Interventions
- 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
Primary outcome measures
- 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.]
Secondary outcome measures (12)
- Cardiac left 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]
- Cardiac right ventricular end-diastolic volume [Time frame: 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. [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- University of Oxford Department of Cardiovascular Medicine — Oxford
Identifiers
NCT: NCT06187012 · 22/LO/0781