Optimising Prescription of Treatment In older patients with Mild hypertension at Increased risk of Serious adverse Events (OPTIMISE2)

niversity of Oxford0 sites3,014 target enrollmentSeptember 19, 2023

ConditionsHypertension Circulatory System

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hypertension
Sponsor: niversity of Oxford
Enrollment: 3014
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 19, 2023

End Date

April 30, 2027

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Oxford

Eligibility Criteria

Inclusion Criteria

•1\.Willing and able to give informed consent for participation in the trial (or with Personal Legal Representative consent)
•2\.Willing and able to report any safety concerns or with a suitable carer able to report these if unable
•3\.Registered at either a practice using electronic health record systems (e.g. EMIS or SystmOne) or contributing to or willing to contribute to ORCHID
•4\.Aged 75 years or above at recruitment.
•5\.Controlled systolic blood pressure, defined (in accordance with NICE 2019 guidelines) as less than 140 mmHg (if aged 75\-79 years) or less than 150 mmHg (if aged 80 years or above). Systolic blood pressure level will be based on screening measurements taken at baseline (mean of the 2nd and 3rd readings taken in a standardised manner) or from patient records.
•6\.Prescribed two or more antihypertensive medications for at least 12 months prior to trial entry. Antihypertensive medications defined as any ACE inhibitor, angiotensin II receptor blocker, calcium channel blocker, thiazide and thiazide\-like diuretic (including loop diuretics), potassium\-sparing diuretic, alpha\-blocker, beta\-blocker, vasodilator antihypertensives, centrally acting antihypertensives, direct renin inhibitors, adrenergic neurone blocking drugs.
•7\.Stable dose of antihypertensive medications for at least four weeks prior to trial entry.
•8\.Moderate or severe frailty (defined by an eFI score \=0\.20\) and/or high risk (\>5%) of hypotension, syncope or falls in the next 5 years, based on STRATIFY risk prediction algorithms applied to an individual’s electronic health record.

Exclusion Criteria

•1\. Heart failure due to left ventricular systolic dysfunction (LVSD) prescribed only ACE inhibitors/angiotensin II receptor blockers and/or beta\-blockers and/or spironolactone (removing any of which would be contraindicated).
•2\. Heart failure diagnosis without a coded echocardiogram (might have undiagnosed LVSD and a compelling need for ACEI/ angiotensin II receptor blocker and beta\-blockers).
•3\. Suffered a myocardial infarction or stroke within the past 6 months.
•4\. Secondary hypertension or previous accelerated or malignant hypertension.
•5\. Lacking capacity to give consent and without a consultee present at the point of screening.
•6\. Participating in any other randomised controlled trial of drug treatment or interventional medical devices in the past 4 weeks (can be re\-invited subsequently).