Physician Optimised Post-partum Hypertension Treatment Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Diastolic Blood pressure (BP)
研究概览
简要总结
It has been shown in a pilot randomised controlled study [SNAP-HT [4]; REC 14/SC/1316] that blood pressure self-management during the post-partum period after hypertensive pregnancies, results in lower blood pressure after six months; even when medication has been stopped. The team now want to assess whether this blood pressure reduction can be reproduced in a larger, randomised, study (data analysis blinded) and whether the blood pressure lowering has additional benefits in terms of other cardiovascular and cerebrovascular changes known to occur in women who have had a hypertensive pregnancy. The investigators therefore plan to run a trial of self-management in the post-partum period, using updated Blue-tooth® enabled blood pressure monitoring coupled to physician-assisted dose titration to further advance the self-management aspect of the intervention. The physicians will be specialist clinicians who form part of the research team. The investigators will measure additional structural and functional end organ differences, using magnetic resonance imaging of the brain and heart as well as echocardiography and retinal imaging. This will provide insight into the impact of post-partum blood pressure control on the maternal cardiovascular system and how this associates with blood pressure changes. Together, these studies will help refine future intervention strategies in this cohort of patients.
详细描述
Summary of the Design ---------------------- The trial is a single centre, single blinded (the investigators will be unaware of which group the participants are allocated to), and randomised controlled study i.e. the group participants are put is allocated by chance. The study focuses on women who develop hypertensive disorders of pregnancy, which require ongoing treatment for blood pressure after birth at the time of discharge. These women will be randomised to one of two treatment arms: either usual care by GP/mid-wife/other NHS providers, or self -management of blood pressure. Women will be recruited from the John Radcliffe Hospital and this study will investigate the effectiveness of post-partum physician assisted self-management of blood pressure vs standard care over the first 6 (up to 9) months post-partum.
Trial Setting and participant profile
------------------------------------ The investigators aim to recruit 200 participants, of which 100 will be randomised to the intervention arm and 100 to the control arm. The intervention arm will comprise tele-monitored (remote) home blood pressure monitoring (including periods of home 24hr blood pressure monitoring) coupled to doctors overseeing medication self-management remotely. The control arm will receive 'standard' levels of NHS care from their GP and midwives and health visitors. All participants will be recruited from the Oxford Women's Centre at the John Radcliffe Hospital, which sees approximately 25 patients per month with hypertensive pregnancies (demonstrated in a local audit).
Trial participants --------------------- All participants will be females of childbearing age >18 years of age. Inclusion in the trial will require a clinician confirmed diagnosis of either gestational hypertension or pre-eclampsia as defined by NICE's latest guideline for this condition (NG 133), and the women must still require anti-hypertensive medication to control their blood pressure at the time of planned discharge.
Summary of the study visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
All downstream data analysis will be done by investigators blinded to the allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the trial.
- •Female, aged 18 years or above.
- •Clinician confirmed diagnosis of either gestational hypertension or pre-eclampsia defined by NICE NG 133
- •Requiring anti-hypertensive medication at the point of discharge from secondary care.
- •Participant has clinically acceptable laboratory results and clinical course post-partum with no other adverse complicating factor requiring prolonged admission post-partum that would make participation unfeasible as judged by the CI. Examples would include stroke sequalae, ongoing DIC, the baby/babies requiring prolonged NICU/SCBU admission of >1 week.
- •In the Investigator's opinion, is able and willing to comply with all trial requirements including ownership of a 'Smart-phone/Tablet' and willing to use the smart-phone app if randomised to that arm.
- •Sufficient competence in English Language to follow the app instructions and partake in the study, as judged by the CI
排除标准
- •Significant renal or hepatic impairment that would affect safe medication titration and adjustment as part of the trial, as deemed by the Investigator.
- •Scheduled elective surgery (excluding caesarean sections) or other procedures requiring general anaesthesia during the trial.
- •Participant with life expectancy of less than 6 months.
- •Any other significant disease or disorder, which, in the opinion of the Investigator, may either, put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- •An absolute contra-indication to MRI (as per MRI safety questionnaire)
- •Women with pre-existing hypertension will be excluded, as this is a separate pathology that would affect the efficacy of the study intervention and affect the primary and secondary outcomes of the study.
- •Additional exclusion criteria specific to the Gadolinium sub-study are:
- •Breast feeding,
- •eGFR <30ml/minute.
结局指标
主要结局
Diastolic Blood pressure (BP)
时间窗: 6 months post-partum
24 hour average diastolic BP measured by 24 hour ambulatory BP monitoring (ABPM)
次要结局
未报告次要终点