Blood pressure targets for the treatment of people with hypertension and cardiovascular disease.
Luis Carlos Saiz, Javier Gorricho, Javier Garjón...
https://pubmed.ncbi.nlm.nih.gov/36398903Actively Recruiting
Led by University College Dublin · Updated on 2024-07-11
142
Participants Needed
1
Research Sites
12 weeks
Total Duration
U
University College Dublin
Lead Sponsor
S
St Vincent's University Hospital, Ireland
Collaborating Sponsor
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
European Blood Pressure Intensive Control After Stroke
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Total: 1 location
1
Mater Misericordiae University Hospital
Dublin, Ireland
Actively Recruiting
K
Katrina Tobin
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Luis Carlos Saiz, Javier Gorricho, Javier Garjón...
https://pubmed.ncbi.nlm.nih.gov/36398903