Hypertension Explored in Long-term Postpartum Follow-up in Later Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-70
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Hypertensive pregnancy
Other interventionParticipants 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Hypertensive pregnancy1 intervention
Trial outcomes
Primary outcomes
1
Cardiac right ventricular mass
Magnetic resonance imaging assessment of cardiac right ventricular mass indexed to body surface area (g/m\^2).
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 outcomes
1
Cardiac left ventricular mass
Magnetic resonance imaging assessment of cardiac left ventricular mass indexed to body surface area (g/m\^2).
Time frame
Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy2
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)
Time frame
Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy3
Cardiac right ventricular stroke volume.
Magnetic resonance imaging assessment of cardiac right ventricular stroke volume indexed to body surface area (ml/m\^2).
Time frame
Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancy4
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).
Time frame
Participants will be recruited at 10 to 25 years post index pregnancy and assessed up to 40 years post index pregnancySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov