Intracerebral Hemorrhage Clinical Trial
— PROHIBIT-ICHOfficial title:
Prevention of Hypertensive Injury to the Brain by Intensive Treatment in IntraCerebral Haemorrhage
PROHIBIT-ICH will randomise participants to compare a strategy of intensive BP treatment (target <120/80 mm Hg) guided by telemetric home monitoring, versus standard primary care (current RCP guideline is 130/80 mm Hg), in 112 adult survivors of hypertension-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.
Status | Recruiting |
Enrollment | 112 |
Est. completion date | February 28, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: 1. Adults (=40 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) 2. Clinical team opinion that BP control since the ICH is not adequate AND the measured SBP prior to randomisation is =130 mm Hg 3. Recruitment soon after ICH, ideally at hospital discharge or within weeks, is encouraged; recruitment at a later stage after ICH is also exceptionally allowed if there is evidence of inadequate BP control AND SBP at randomisation is =130 mm Hg 4. For patients recruited in hospital there should be a plan for home discharge (not to a nursing or care home) after their inpatient stay, or living at home at the time of recruitment 5. Willingness and demonstration of ability to undertake home BP measurements, either unassisted or with the help of a relative, friend or carer 6. Ability and willingness to complete an MRI scan 7. Ability and willingness to attend and complete the study assessments including cognitive screen 8. 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) Exclusion Criteria: 1. Inability to provide informed consent or lack of suitable consultee (if unable to provide personal consent, lack of suitable consultee) 2. Evidence of a macrovascular or structural cause for ICH (e.g. AVM or tumour) 3. Diagnosis of dementia (DSM IV criteria, or self-reported or documented in medical records) 4. Low Functional status (MRS =4) before or after ICH or frailty likely to make participation in 1-year follow-up difficult for the participant 5. Life expectancy <2 years 6. Taking more than 2 BP-lowering medications (i.e. 3 or more) at the time of consent 7. 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 8. Known flow-restricting intracranial/extracranial large arterial stenosis 9. Known contraindication to MRI 10. Known absence of mobile phone coverage from all network operators and home internet at the participant's home 11. 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 12. Note that participation in other CTIMP or device trial is NOT an automatic exclusion criterion |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal United Hospitals Bath | Bath | |
United Kingdom | West Suffolk Hospital | Bury St Edmunds | |
United Kingdom | Cambridge | Cambridge | |
United Kingdom | Edinburgh | Edinburgh | |
United Kingdom | Glasgow | Glasgow | |
United Kingdom | Croydon University Hospital | London | |
United Kingdom | Imperial | London | |
United Kingdom | King's | London | |
United Kingdom | St George's | London | |
United Kingdom | UCLH | London | |
United Kingdom | Luton & Dunstable Hospital | Luton | |
United Kingdom | Nottingham | Nottingham | |
United Kingdom | Oxford | Oxford | |
United Kingdom | Royal Preston | Preston | |
United Kingdom | Salford | Salford | |
United Kingdom | Sheffield | Sheffield |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The efficacy of telemetric BP monitoring to guide intensive BP treatment in ICH survivors by detecting a statistically significant reduction in BP in the intervention compared to the control arm at 3 months. | Difference in systolic BP between the intervention and control arms at 3 months | 3 months from randomisation | |
Primary | The feasibility of telemetric BP lowering in ICH survivors by detection of how many eligible participants agree | Feasibility criteria are at least =50% of eligible participants agree to participate | 3 months from randomisation | |
Primary | The feasibility of telemetric BP lowering in ICH survivors by detection of how many drop out in the intervention arm | <30% dropout from the intervention arm (discontinuation of home BP monitoring against the advice of the BP monitoring centre) prior to 1 month | 3 months from randomisation | |
Primary | The feasibility of telemetric BP lowering in ICH survivors by detecting patient approval of the device detected by the acceptability questionnaire | Patient approval of the monitoring process in =70% of those randomised to the intervention arm. | 3 months from randomisation | |
Primary | Efficacy of brain imaging by detecting the progression in MRI white matter hyperintensity (WMH) volume over 1 year | This will detected in both arms and compared | 12 months from randomisation | |
Primary | The safety of telemetric BP lowering in ICH survivors measured by serious adverse events | Safety is measured by serious adverse events related to reducing BP in the intervention arm | 12 months from randomisation | |
Secondary | Incidence of recurrent vascular events | Any incidence of vascular events reported in both arms | 12 months from randomisation | |
Secondary | Cognitive ability assessed by the Cognitive Assessment (MoCA) questionnaire in both arms | The Cognitive Assessment is a questionnaire widely used as a screening assessment for detecting cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. An abbreviated version of the assessment assessing attention, verbal learning, memory, executive functions/language and orientation can be performed over the phone. | 12 months from randomisation | |
Secondary | The number of BP lowering drugs at 3 months and at 1 year follow-up visits | This will detected in both arms and compared | 12 months from randomisation | |
Secondary | mean daytime BP at 1 year on 24-hour ABPM | The blood pressure measured in both groups | 12 months from randomisation | |
Secondary | Neuroimaging outcomes: the proportion of patients who develop new cerebral microbleeds (CMBs) over 1 year | neuroimaging outcomes will be measured in both arms | 12 months from randomisation | |
Secondary | Neuroimaging outcomes: the proportion of patients who develop new infarcts or intracerebral haemorrhages at 1 year | neuroimaging outcomes will be measured in both arms | 12 months from randomisation | |
Secondary | Neuroimaging outcomes: measure change in mean diffusivity (MD) | neuroimaging outcomes will be measured in both arms | 12 months from randomisation | |
Secondary | Neuroimaging outcomes: measure fractional anisotropy (FA) | neuroimaging outcomes including (but not limited to) ; ; change in mean diffusivity (MD), fractional anisotropy (FA) and other 3T DTI metrics; change in cerebral blood flow (CBF) on 3T PCASL; change in total brain volume, white matter volume and grey matter volume on 3T T1 volumetric images; composite neuroimaging measures (e.g summary SVD scores) | 12 months from randomisation | |
Secondary | Neuroimaging outcomes: measure change in brain volume | neuroimaging outcomes including (but not limited to) : change in cerebral blood flow (CBF) on 3T PCASL; change in total brain volume, white matter volume and grey matter volume on 3T T1 volumetric images; composite neuroimaging measures (e.g summary SVD scores) | 12 months from randomisation |
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