Optimising prescription of treatment in older patients with mild hypertension (high blood pressure) at increased risk of serious adverse events

Phase 4

• Conditions: Hypertension; Circulatory System

• Registration Number: ISRCTN18030225
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-19
• Last Update Posted: 23 October 2023
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3014

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emergency hospitalisation (all-cause admissions which are unpredictable and at short notice because of clinical need; [admission for at least 1 day overnight]) or death measured at 1 year post-randomisation