Prevention of Hypertensive Injury to the Brain by Intensive Treatment of Blood Pressure After Intracerebral Haemorrhage (PROHIBIT-ICH)

NCT03863665 | Terminated

• 1 other identifier: PROHIBIT-ICH01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Keywords

Blood pressure; Hypertension; Secondary prevention

Outcome Measures

Primary Outcomes (5)

• BP Study: Efficacy

  Magnitude of difference in assessment BP at 3 months in the intervention arm versus the control arm compared with baseline measures

  3 months from randomisation

• BP Study: Feasibility

  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.

  3 months from randomisation

• BP Study: Safety

  Serious adverse events related to reducing BP in intervention arm

  3 months from randomisation

• Imaging Study: Efficacy

  Progression in MRI white matter hyperintensity (WMH) volume since baseline

  12 months from randomisation

• Imaging Study: Safety

  Evolution of new infarcts or ICH on 12-month follow-up MRI

  12 months from randomisation

Secondary Outcomes (9)

• 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

Study Arms (2)

Telemetric Bluetooth-enabled home BP monitors

EXPERIMENTAL

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

Standard clinical care

NO INTERVENTION

Standard clinical care including usual BP treatment, without home monitoring, undertaken in the clinical care setting (primary and/or secondary care)

Interventions

A&D BP Digital Blood Pressure Monitor (UA-767PBT-Ci) CE Declaration UA-767PBT-Ci DEVICE

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.

Telemetric Bluetooth-enabled home BP monitors

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• University of Oxford: collaborator
• The Stroke Association, United Kingdom: collaborator

Study Sites (16)

Royal United Hospitals Bath

Bath, United Kingdom

Location

West Suffolk Hospital

Bury St Edmunds, United Kingdom

Location

Cambridge

Cambridge, CB2 0QQ, United Kingdom

Location

Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Glasgow

Glasgow, G51 4TF, United Kingdom

Location

King's

London, SE5 8AF, United Kingdom

Location

St George's

London, SW17 0QT, United Kingdom

Location

Imperial

London, W12 0HS, United Kingdom

Location

UCLH

London, WC1B 5EH, United Kingdom

Location

Croydon University Hospital

London, United Kingdom

Location

Luton & Dunstable Hospital

Luton, United Kingdom

Location

Nottingham

Nottingham, NG5 1PB, United Kingdom

Location

Oxford

Oxford, OX3 9DU, United Kingdom

Location

Royal Preston

Preston, PR2 9HT, United Kingdom

Location

Salford

Salford, M6 8HD, United Kingdom

Location

Sheffield

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (1)

• Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.

  PMID: 34022170 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Hypertension

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Werring

  University College, London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers undertaking the neuroimaging analysis are masked to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: March 5, 2019
• Study Start: March 11, 2019
• Primary Completion: May 5, 2022
• Study Completion: April 29, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

GB (16)