Actively Recruiting

Phase 2
Age: 40Years +
All Genders
ID04647292

European Blood Pressure Intensive Control After Stroke - Pilot Trial

Led by University College Dublin · Updated on 2024-07-11

142

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

U

University College Dublin

Lead Sponsor

S

St Vincent's University Hospital, Ireland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Stroke is a leading cause of death and disability worldwide, with high blood pressure being a major risk factor for stroke recurrence and cardiovascular events. This research aims to evaluate whether home blood pressure monitoring combined with telemonitoring and medication adjustment can better control blood pressure compared to standard office-based care in patients who have recently experienced an ischemic stroke or transient ischemic attack (TIA). The study is a phase 2 pilot trial designed to assess feasibility for a larger future study. Participants will be randomly assigned to one of two groups: one group will use home blood pressure measurement and telemonitoring alongside medication titration guided by a treatment algorithm, while the other group will receive standard blood pressure management by their physician according to current guidelines. Medication choices include diuretics, ACE inhibitors, and calcium-channel blockers, with regular review and adjustments made based on blood pressure readings. The study is conducted over a 12-month period. During the study, participants will have their blood pressure monitored regularly at home or in the office, with the research team reviewing data to guide treatment. Outcomes measured include differences in average systolic blood pressure after 12 months, the proportion of patients reaching target blood pressure, time taken to reach targets, adverse events, quality of life, cognitive changes, and patient feedback. Safety and adherence will also be monitored throughout the trial, which is sponsored by University College Dublin.

CONDITIONS

Brief Title

European Blood Pressure Intensive Control After Stroke

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 years or older
  • Recent ischemic stroke or high-risk transient ischemic attack confirmed by brain CT or MRI
  • Living at home and independent, able to walk without help but may have some assistance with daily activities
  • Systolic blood pressure of 140 mmHg or higher at entry
  • Stroke or TIA event occurred between 30 days and 1 year before randomization
  • Estimated glomerular filtration rate (eGFR) of 50 ml/min/m2 or higher within 3 months
  • Medically stable and able to participate in home blood pressure monitoring and the trial
  • Willing and able to provide informed consent (no surrogate consent)
Not Eligible

You will not qualify if you...

  • Systolic blood pressure less than 110 mmHg after standing for 3 minutes or contraindication to intensive blood pressure lowering (e.g., fainting, recurrent falls)
  • Stroke caused by intracerebral hemorrhage, cardio-embolism, or other specific causes
  • Severe narrowing or blockage (greater than 70%) of large neck or brain arteries
  • Severe illness or conditions likely to prevent compliance (e.g., dementia, active cancer, severe frailty, inability to travel)
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 12 months

Participants are randomized to either home blood pressure measurement with telemonitoring and medication titration or to standard of care blood pressure management with antihypertensive therapy to reach a target systolic blood pressure below 130 mmHg.

Monthly visits for medication review and blood pressure monitoring

Trial Site Locations

Total: 1 location

1

Mater Misericordiae University Hospital

Dublin, Ireland

Actively Recruiting

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Research Team

K

Katrina Tobin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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