Clinical trial NCT04647292: European Blood Pressure Intensive Control After Stroke
Official title: European Blood Pressure Intensive Control After Stroke - Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: ischemic stroke
transient ischemic attack
blood pressure
hypertension
recurrence
prognosis
prevention
randomized control trial
myocardial infarction
vascular events
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: St Vincent's University Hospital, Ireland
name: Cork University Hospital
name: Tallaght University Hospital
name: HRB Stroke Trials Network Ireland
name: National University of Ireland, Galway, Ireland
name: Mater Misericordiae University Hospital
name: St. James's Hospital, Ireland
name: Connolly Hospital Blanchardstown
First posted: 2020-11-30
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥40
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:

1. 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)
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

Primary outcomes:
measure: Difference in mean SBP
timeFrame: 12 months (or last trial visit)
Secondary outcomes:
measure: Proportions of patients assigned to each arm successfully reaching guideline-based target (SBP<130mmHg) at end of trial visit
timeFrame: 12 months (or last trial visit)
measure: Time in guideline-based target range
timeFrame: 12 months (or last trial visit)
measure: Time taken to reach target
timeFrame: 12 months (or last trial visit)
measure: Difference in mean diastolic blood pressure (DBP) between groups
timeFrame: 12 months (or last trial visit)
measure: Change in SBP/DBP from baseline to end-of-trial
timeFrame: 12 months (or last trial visit)
measure: Time to first composite major adverse cardiovascular event (MACE), and to each component of the composite, stratified as fatal, non-fatal and total
timeFrame: 12 months (or last trial visit)
measure: All-cause fatality
timeFrame: 12 months (or last trial visit)
measure: Comparison of disability in each intervention arm assessed by modified Rankin score
timeFrame: 12 months (or last trial visit)
measure: Number of dose-titrations required
timeFrame: 12 months (or last trial visit)
measure: Time required per follow up visit
timeFrame: 12 months (or last trial visit)
measure: Number of patients lost to follow-up
timeFrame: 12 months (or end of trial visit)
measure: Number of serious adverse events
timeFrame: 12 months (or last trial visit)
measure: Number of pre-specified adverse events
timeFrame: 12 months (or last trial visit)
measure: Change in health related quality of life
timeFrame: 12 months (or last trial visit)
measure: Change in cognition
timeFrame: 12 months (or last trial visit)
measure: Qualitative patient feedback obtained via workshops and questionnaires
timeFrame: 12 months (or last trial visit)
Other outcomes:
measure: Number of patients who do not complete the study due to tolerability or other issues
timeFrame: 12 months (or end of trial visit)
measure: Ability of sites to rapidly identify eligible patients from clinics and stroke units
timeFrame: 12 months (or end of trial visit)
measure: Feasibility of home blood pressure (BP) measures and telemonitoring
timeFrame: 12 months (or end of trial visit)
measure: Compliance with telemonitoring and feasibility of remote (phone) visits
timeFrame: 12 months (or end of trial visit)
measure: Feasibility of remote BP titration
timeFrame: 12 months (or end of trial visit)
measure: Barriers to participation of women
timeFrame: 12 months (or end of trial visit)
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
Study officials:
References:
citation: 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.