European Blood Pressure Intensive Control After Stroke - Pilot Trial

Who is this study for? Patients with Ischemic Stroke, Transient Ischemic Attack
What treatments are being studied? Anti-Hypertensive
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Age ≥40

• 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)

Locations
Other Locations
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
Contact Information
Primary
Katrina Tobin
katrina.tobin@ucd.ie
+353 1 716 4576
Time Frame
Start Date: 2024-05-02
Estimated Completion Date: 2026-03
Participants
Target number of participants: 142
Treatments
Experimental: Home Blood Pressure Measurement, Telemonitoring and Medication titration
Medication titration to guideline SBP \<130mmHg
Active_comparator: 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
Sponsors
Leads: University College Dublin
Collaborators: Mater Misericordiae University Hospital, St. James's Hospital, Ireland, St Vincent's University Hospital, Ireland, National University of Ireland, Galway, Ireland, HRB Stroke Trials Network Ireland, Cork University Hospital, Tallaght University Hospital, Connolly Hospital Blanchardstown

This content was sourced from clinicaltrials.gov