Study Results
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Basic Information
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RECRUITING
PHASE2
142 participants
INTERVENTIONAL
2024-05-02
2026-03-31
Brief Summary
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Home blood pressure measurement and telemonitoring are acceptable to patients, but there is uncertainty over the use of out of office blood pressure measurements in stroke patients in guidelines.
This is a study designed to establish the feasibility of a larger clinical trial, comparing home blood pressure monitoring, telemonitoring and medication titration with standard care. The study hypothesis is that home BP measurement and telemonitoring with medication titration may lead to improved BP control compared to standard of care clinical practice.
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Detailed Description
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Stroke is the third leading cause of global death, the leading cause of acquired disability and contributes substantially to dementia, cognitive decline, and healthcare costs. Global epidemiological studies such as INTERSTROKE and the Global Burden of Disease study estimated that hypertension is the leading modifiable risk factor for stroke, with a population attributable risk of approximately 50%. Recurrent vascular events (stroke, coronary events, vascular death) cause significant morbidity in ischaemic stroke survivors, affecting approximately 30% at 5 years.
High rates of failure to achieve guideline BP targets (\<130mmHg) are reported in clinical practice for patients following ischaemic stroke or TIA. Home blood pressure measurement and telemonitoring is recognised as acceptable to patients from previous studies, and some trials have noted a significant reduction in BP at 12 months. The latest ESO guidelines note continued uncertainty over the use of out-of-office blood pressure measurements for adult patients with ischaemic stroke or TIA due to insufficient data.
This trial will recruit patients with recent stroke/TIA events with systolic BP ≥140 mmHg and randomise them to standard of care or home BP monitoring with telemonitoring and medication titration. The study hypothesis is that home BP measurement and telemonitoring with medication titration may lead to improved BP control compared to standard of care clinical practice.
Aim:
The aim is to conduct an initial pilot randomised trial in Ireland and European centres involved in the European Stroke Organisation Trials Alliance. This feasibility study will assess key design aspects and establish trial governance, data management, and procedures in preparation for a larger definitive trial.
Methods:
Design: Prospective, open-label, blinded endpoint assessed (PROBE) randomised, parallel group pilot/feasibility clinical trial, comparing BP patient self-measurement and telemonitoring with office-based monitoring (standard of care) for improved BP control after ischaemic stroke/TIA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Home Blood Pressure Measurement, Telemonitoring and Medication titration
Medication titration to guideline SBP \<130mmHg
anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration
A medication algorithm based on the SPRINT trial protocol will be provided for patients in the home blood pressure measurement arm. The final choice and dose of antihypertensive treatment(s) will be at the discretion of the treating clinicians. If no contra-indications, indapamide or other thiazide diuretic and/or angiotensin-converting enzyme (ACE) inhibitor (perindopril or other) will be encouraged as initial therapy, with long-acting calcium-channel antagonists (eg.amlodipine) encouraged as third-line therapy.
Patients will have their home blood pressure monitoring diary reviewed by the study team. If SBP is out of the allocated target range, a prescription to titrate antihypertensive medication will be sent to the patient at least monthly.
Control Group: Standard of Care Blood Pressure Management
Standard of Care Management by GP/physician to SBP \<130mmHg by current European Stroke Organisation, American Stroke Association and UK NICE guidelines
Standard of Care Blood Pressure Management with Antihypertensives
Participants in the standard of care arm will receive antihypertensive therapy at the physician's discretion to the same treatment target of SBP \<130mmHg.
Interventions
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anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration
A medication algorithm based on the SPRINT trial protocol will be provided for patients in the home blood pressure measurement arm. The final choice and dose of antihypertensive treatment(s) will be at the discretion of the treating clinicians. If no contra-indications, indapamide or other thiazide diuretic and/or angiotensin-converting enzyme (ACE) inhibitor (perindopril or other) will be encouraged as initial therapy, with long-acting calcium-channel antagonists (eg.amlodipine) encouraged as third-line therapy.
Patients will have their home blood pressure monitoring diary reviewed by the study team. If SBP is out of the allocated target range, a prescription to titrate antihypertensive medication will be sent to the patient at least monthly.
Standard of Care Blood Pressure Management with Antihypertensives
Participants in the standard of care arm will receive antihypertensive therapy at the physician's discretion to the same treatment target of SBP \<130mmHg.
Eligibility Criteria
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Inclusion Criteria
2. Ischaemic stroke1, high-risk TIA, proven by imaging (brain CT/MRI)
3. Living at home and independent (walking without the aid of another person, but may have some help for daily activities)
4. SBP≥140mmHg at entry (average of 2 measures, seated, in the same arm, after resting alone in office for 10 minutes)
5. Qualifying event between 30 days and 1 year of randomisation
6. Glomerular filtration rate (eGFR) greater than or equal to 50ml/min/m2 (within 3 months of randomisation)
7. Medically-stable and capable of participating in a randomised trial, including home BP measures, in the opinion of the study physician
8. Willing to provide informed consent (no surrogate consent will apply)
Exclusion Criteria
2. Qualifying stroke due to intracerebral haemorrhage (ICH), cardio-embolism or other defined causes (eg. dissection, endocarditis, other specified)
3. Severe stenosis or occlusion of large cranio-cervical artery (\>70% stenosis/occlusion of cervical carotid, vertebral, or Circle of Willis artery)
4. Unlikely to comply with study procedures due to severe or fatal comorbid illness (eg. dementia, active malignancy, severe frailty) or other factor (eg. inability to travel)
5. Pregnancy or breastfeeding
40 Years
ALL
No
Sponsors
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St Vincent's University Hospital, Ireland
OTHER
Cork University Hospital
OTHER
Tallaght University Hospital
OTHER
HRB Stroke Trials Network Ireland
UNKNOWN
National University of Ireland, Galway, Ireland
OTHER
Mater Misericordiae University Hospital
OTHER
St. James's Hospital, Ireland
OTHER
Connolly Hospital Blanchardstown
OTHER
University College Dublin
OTHER
Responsible Party
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Locations
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Mater Misericordiae University Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
Other Identifiers
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7580
Identifier Type: -
Identifier Source: org_study_id
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