European Blood Pressure Intensive Control After Stroke

NCT04647292 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-07-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • St Vincent's University Hospital, Ireland

    collaborator OTHER
  • Cork University Hospital

    collaborator OTHER
  • Tallaght University Hospital

    collaborator OTHER
  • HRB Stroke Trials Network Ireland

    collaborator UNKNOWN
  • National University of Ireland, Galway, Ireland

    collaborator OTHER
  • Mater Misericordiae University Hospital

    collaborator OTHER
  • St. James's Hospital, Ireland

    collaborator OTHER
  • Connolly Hospital Blanchardstown

    collaborator OTHER
  • University College Dublin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Ireland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647292 on ClinicalTrials.gov