European Blood Pressure Intensive Control After Stroke - Pilot Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- University College Dublin
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Difference in mean SBP
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Stroke is the third most common cause of death worldwide and the leading cause of disability. High blood pressure is an important risk factor for stroke. Lowering a person's blood pressure reduces the risk of future stroke or heart attack, and current guidelines recommend treatment to a target of <130mmHg for secondary prevention.
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.
Detailed Description
Background: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ischaemic stroke1, high-risk TIA, proven by imaging (brain CT/MRI)
- •Living at home and independent (walking without the aid of another person, but may have some help for daily activities)
- •SBP≥140mmHg at entry (average of 2 measures, seated, in the same arm, after resting alone in office for 10 minutes)
- •Qualifying event between 30 days and 1 year of randomisation
- •Glomerular filtration rate (eGFR) greater than or equal to 50ml/min/m2 (within 3 months of randomisation)
- •Medically-stable and capable of participating in a randomised trial, including home BP measures, in the opinion of the study physician
- •Willing to provide informed consent (no surrogate consent will apply)
Exclusion Criteria
- •SBP \<110mmHg after 3 minutes of standing or other contra-indication to intensive SBP lowering in opinion of treating clinician (eg. Orthostatic symptoms, syncope or pre syncope, recurrent falls)
- •Qualifying stroke due to intracerebral haemorrhage (ICH), cardio-embolism or other defined causes (eg. dissection, endocarditis, other specified)
- •Severe stenosis or occlusion of large cranio-cervical artery (\>70% stenosis/occlusion of cervical carotid, vertebral, or Circle of Willis artery)
- •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)
- •Pregnancy or breastfeeding
Outcomes
Primary Outcomes
Difference in mean SBP
Time Frame: 12 months (or last trial visit)
The difference in mean SBP between both groups, at 12 months (or last trial visit)
Secondary Outcomes
- Number of dose-titrations required(12 months (or last trial visit))
- Number of pre-specified adverse events(12 months (or last trial visit))
- Time in guideline-based target range(12 months (or last trial visit))
- Time to first composite major adverse cardiovascular event (MACE), and to each component of the composite, stratified as fatal, non-fatal and total(12 months (or last trial visit))
- Time taken to reach target(12 months (or last trial visit))
- Number of patients lost to follow-up(12 months (or end of trial visit))
- Difference in mean diastolic blood pressure (DBP) between groups(12 months (or last trial visit))
- All-cause fatality(12 months (or last trial visit))
- Change in SBP/DBP from baseline to end-of-trial(12 months (or last trial visit))
- Proportions of patients assigned to each arm successfully reaching guideline-based target (SBP<130mmHg) at end of trial visit(12 months (or last trial visit))
- Number of serious adverse events(12 months (or last trial visit))
- Comparison of disability in each intervention arm assessed by modified Rankin score(12 months (or last trial visit))
- Change in health related quality of life(12 months (or last trial visit))
- Time required per follow up visit(12 months (or last trial visit))
- Change in cognition(12 months (or last trial visit))
- Qualitative patient feedback obtained via workshops and questionnaires(12 months (or last trial visit))