Prevention of Hypertensive Injury to the Brain by Intensive Treatment of Blood Pressure After Intracerebral Haemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 28
- 主要终点
- BP Study: Efficacy
研究概览
简要总结
PROHIBIT-ICH will randomise participants (target=112) to compare a strategy of intensive blood pressure (BP) treatment (target <120/80 mm Hg) guided by remote telemetric home BP monitoring, versus standard primary care, in adult survivors of small vessel disease-related ICH. The investigators will establish the feasibility and safety of the intervention, the efficacy of BP reduction, and explore whether it reduces the progression of SVD-related injury on brain MRI.
详细描述
Eligible participants will be identified from acute stroke or high dependency units or outpatient clinics (neurology, geriatric, and neurosurgery) by a member of the research practitioner or member of research/clinical teams. Patients may be under the care of stroke physicians, geriatricians, neurologists, or neurosurgeons.
Baseline:
At baseline, the following trial specific procedures will be carried out after consent as a requirement for the study to commence:
- Medical history and demographic data recorded
- Blood pressure medication and dose recorded
- Blood pressure (BP), three seated office measures
- Blood test (venepuncture)
- MRI brain
- Cognitive assessment (Montreal Cognitive Assessment)
- Completion of an EQ-5D questionnaire
- 24-hour ABPM
Randomisation will be done using a web-based system in a 1:1 group assignment ratio to intensive remote telemetric home BP monitoring (RT-HBPM)-guided BP lowering (intervention group) or local primary care alone (control group), with stratification by ICH location (lobar versus non-lobar). In the intervention group, BP medication will adjusted on the basis of daily review of BP measures by the study physician in the central BP-monitoring team to target during 1-3 months to target a daily mean HBPM BP <120/80 mmHg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Researchers undertaking the neuroimaging analysis are masked to the treatment allocation.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥30 years) with spontaneous primary ICH (i.e. without known underlying structural, macrovascular or other cause (e.g. arteriovenous malformation, tumour) after adequate investigation at the discretion of the local investigator). This will include participants presumed to have cerebral SVD (both hypertensive arteriopathy and cerebral amyloid angiopathy)
- •Clinical team opinion that BP control since the ICH is not adequate AND the measured SBP prior to randomisation is ≥130 mm Hg
- •There is no time limit for recruitment; however, recruitment as soon as is practical after the ICH is encouraged. Recruitment at a later stage is acceptable as long as there is evidence of inadequate BP control AND SBP at randomisation is ≥130 mm Hg
- •Ability and willingness to undertake BP measurements,, either unassisted or with the help of a relative, friend or carer: this can be undertaken in any destination after hospital discharge (e.g. home, rehabilitation unit, nursing or care home)
- •Ability and willingness to attend and complete the study assessments including cognitive screen
- •Ability and willingness to provide informed consent, or with a suitable consultee available and able to participate in the intervention (e.g. with a motivated carer)
排除标准
- •Inability to provide informed consent or lack of suitable consultee (if unable to provide personal consent, lack of suitable consultee)
- •Evidence of a macrovascular or structural cause for ICH (e.g. AVM or tumour)
- •Diagnosis of dementia (DSM IV criteria, or self-reported or documented in medical records)
- •Low Functional status (MRS ≥4) before or after ICH or frailty likely to make participation in 1-year follow-up difficult for the participant
- •Life expectancy <2 years
- •Taking more than 2 BP-lowering medications (i.e. 3 or more) at the time of consent
- •Consistently good BP control (below 130/80 mm Hg on measures taken as part of routine clinical care) prior to planned recruitment, judged not to require more intensive treatment
- •Known flow-restricting intracranial/extracranial large arterial stenosis
- •Known absence of mobile phone coverage from all network operators and home internet at the participant's home
- •Known sensitivity or contra-indication to BP treatments (e.g. symptomatic postural hypotension) is not an absolute exclusion criterion, but more information must be provided
- •Note that participation in other CTIMP or device trial is NOT an automatic exclusion criterion
结局指标
主要结局
BP Study: Efficacy
时间窗: 3 months from randomisation
Magnitude of difference in assessment BP at 3 months in the intervention arm versus the control arm compared with baseline measures
BP Study: Feasibility
时间窗: 3 months from randomisation
At least ≥50% of eligible participants agree to participate, \<30% dropout from the intervention arm (discontinuation of home BP monitoring against the advice of the BP monitoring centre) prior to 1 month, Patient approval of the monitoring process in ≥70% of those randomised to the intervention arm.
BP Study: Safety
时间窗: 3 months from randomisation
Serious adverse events related to reducing BP in intervention arm
Imaging Study: Efficacy
时间窗: 12 months from randomisation
Progression in MRI white matter hyperintensity (WMH) volume since baseline
Imaging Study: Safety
时间窗: 12 months from randomisation
Evolution of new infarcts or ICH on 12-month follow-up MRI
次要结局
- Incidence of recurrent vascular events(12 months from randomisation)
- Cognitive ability assessed by the Cognitive Assessment (MoCA) questionnaire in both arms(12 months from randomisation)
- The number of BP lowering drugs at 3 months and at 1 year follow-up visits(12 months from randomisation)
- Mean daytime BP at 1 year on 24-hour ABPM(12 months from randomisation)
- Neuroimaging outcomes: the proportion of patients who develop new cerebral microbleeds (CMBs) over 1 year(12 months from randomisation)
- Neuroimaging outcomes: the proportion of patients who develop new infarcts or intracerebral haemorrhages at 1 year(12 months from randomisation)
- Neuroimaging outcomes: measure change in mean diffusivity (MD)(12 months from randomisation)
- Neuroimaging outcomes: measure fractional anisotropy (FA)(12 months from randomisation)
- Neuroimaging outcomes: measure change in brain volume(12 months from randomisation)