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Prevention of Hypertensive Injury to the Brain by Intensive Treatment in IntraCerebral Haemorrhage (PROHIBIT-ICH) (PROHIBIT-ICH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03863665
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Device: A&D BP Digital Blood Pressure Monitor (UA-767PBT-Ci) CE Declaration UA-767PBT-Ci Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomised in a 1:1 ratio to intervention or control arms of the study. Participants and their physicians will not be blinded to study arm allocation
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prevention of Hypertensive Injury to the Brain by Intensive Treatment in IntraCerebral Haemorrhage
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Telemetric Bluetooth home BP monitors
Telemetric Bluetooth home BP monitors will be provided to participants during their inpatient stay or clinic visit, and will commence 3- times-daily readings immediately. The BP monitoring team will assess BP readings daily and advise medication adjustments to achieve a target BP of <120/80 mm Hg
Device: A&D BP Digital Blood Pressure Monitor (UA-767PBT-Ci) CE Declaration UA-767PBT-Ci
Telemetric home monitoring is a promising strategy to facilitate home BP monitoring after stroke, which should improve adherence and optimize medication to better control BP. Telemetry allows patients with hypertension to monitor their own BP and automatically send the information to a secure website, available to their clinicians to monitor and adjust their treatment.

No Intervention: Standard clinical care
Standard clinical care including usual BP treatment, without home monitoring, undertaken in the clinical care setting



Primary Outcome Measures :
  1. 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. [ Time Frame: 3 months from randomisation ]
    Difference in systolic BP between the intervention and control arms at 3 months

  2. The feasibility of telemetric BP lowering in ICH survivors by detection of how many eligible participants agree [ Time Frame: 3 months from randomisation ]
    Feasibility criteria are at least ≥50% of eligible participants agree to participate

  3. The feasibility of telemetric BP lowering in ICH survivors by detection of how many drop out in the intervention arm [ Time Frame: 3 months from randomisation ]
    <30% dropout from the intervention arm (discontinuation of home BP monitoring against the advice of the BP monitoring centre) prior to 1 month

  4. The feasibility of telemetric BP lowering in ICH survivors by detecting patient approval of the device detected by the acceptability questionnaire [ Time Frame: 3 months from randomisation ]
    Patient approval of the monitoring process in ≥70% of those randomised to the intervention arm.

  5. Efficacy of brain imaging by detecting the progression in MRI white matter hyperintensity (WMH) volume over 1 year [ Time Frame: 12 months from randomisation ]
    This will detected in both arms and compared

  6. The safety of telemetric BP lowering in ICH survivors measured by serious adverse events [ Time Frame: 12 months from randomisation ]
    Safety is measured by serious adverse events related to reducing BP in the intervention arm


Secondary Outcome Measures :
  1. Incidence of recurrent vascular events [ Time Frame: 12 months from randomisation ]
    Any incidence of vascular events reported in both arms

  2. Cognitive ability assessed by the Cognitive Assessment (MoCA) questionnaire in both arms [ Time Frame: 12 months from randomisation ]
    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.

  3. The number of BP lowering drugs at 3 months and at 1 year follow-up visits [ Time Frame: 12 months from randomisation ]
    This will detected in both arms and compared

  4. mean daytime BP at 1 year on 24-hour ABPM [ Time Frame: 12 months from randomisation ]
    The blood pressure measured in both groups

  5. Neuroimaging outcomes: the proportion of patients who develop new cerebral microbleeds (CMBs) over 1 year [ Time Frame: 12 months from randomisation ]
    neuroimaging outcomes will be measured in both arms

  6. Neuroimaging outcomes: the proportion of patients who develop new infarcts or intracerebral haemorrhages at 1 year [ Time Frame: 12 months from randomisation ]
    neuroimaging outcomes will be measured in both arms

  7. Neuroimaging outcomes: measure change in mean diffusivity (MD) [ Time Frame: 12 months from randomisation ]
    neuroimaging outcomes will be measured in both arms

  8. Neuroimaging outcomes: measure fractional anisotropy (FA) [ Time Frame: 12 months from randomisation ]
    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)

  9. Neuroimaging outcomes: measure change in brain volume [ Time Frame: 12 months from randomisation ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863665


Contacts
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Contact: Shahena Butt 0203 108 6181 shahena.butt@ucl.ac.uk

Locations
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United Kingdom
Cambridge Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Jobbin Francis       jobbin.francis@addenbrookes.nhs.uk   
Principal Investigator: Niamh Hannon         
Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SB
Contact: Allan Macraild       allan.macraild@nhslothian.scot.nhs.uk   
Principal Investigator: Rustam Al-Shahi Salman         
Glasgow Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Angela Welch       angelawelch@nhs.net   
Principal Investigator: Keith Muir         
King's Recruiting
London, United Kingdom, SE5 8AF
Contact: Maria Tibajia       mtibajia@nhs.net   
Principal Investigator: Dulka Manawadu         
St George's Recruiting
London, United Kingdom, SW17 0QT
Contact: Sarah Stratton       sarah.stratton@nhs.net   
Principal Investigator: Liqun Zhang         
Imperial Recruiting
London, United Kingdom, W12 0HS
Contact: Peter Wilding       peter.wilding@nhs.net   
Principal Investigator: Soma Banerjee         
UCLH Recruiting
London, United Kingdom, WC1B 5EH
Contact: Anna Robinson       anna.robinson7@nhs.net   
Principal Investigator: David Werring         
Nottingham Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Gwendoline Wilkes       Gwendoline.wilkes@nottingham.ac.uk   
Principal Investigator: Kailash Krishnan         
Oxford Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Michelle Wilson       michelle.wilson@ndcn.ox.ac.uk   
Principal Investigator: Peter Rothwell         
Royal Preston Recruiting
Preston, United Kingdom, PR2 9HT
Contact: Heather Adams       Heather.ADAMS@lthtr.nhs.uk   
Principal Investigator: Hedley Emsley         
Salford Recruiting
Salford, United Kingdom, M6 8HD
Contact: Stephanie Lee       Stephanie.Lee@srft.nhs.uk   
Principal Investigator: Adrian Parry-Jones         
Sheffield Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Emma Richards       Emma.Richards@sth.nhs.uk   
Principal Investigator: Kirsty Harkness         
Sponsors and Collaborators
University College, London
Investigators
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Study Chair: David Werring University College, London
  Study Documents (Full-Text)

Documents provided by University College, London:
Study Protocol  [PDF] June 13, 2018

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03863665    
Other Study ID Numbers: PROHIBIT-ICH01
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases