Hypertension Circulatory System
Conditions
Interventions
The trial intervention is step down anti-hypertensive medication reduction versus usual care. Randomisation will be performed using a fully validated web-based randomisation system (Sortition) with st
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
75 Years to 120 Years
Inclusion 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
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). (added 19/12/2024) 7. Investigator deems that there is a compelling indication for medication continuation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured through remote assessment of health records at 1 year post-randomisation: 1. Major cardiovasular events (Four-point definition: non-fatal acute myocardial infarction, non-fatal stroke, non-fatal heart failure and cardiovascular death) 2. Myocardial infarction 3. Stroke 4. Heart Failure 5. Falls 6. Serious hypotension 7. Serious syncope 8. Serious fracture 9. Dementia 10. Serious Adverse Events 11. All-cause death, adverse events, adverse drug withdrawal events, admission to nursing home or care facility through remote assessment of health records at 1 year post-randomisation. 12. Maintenance of medication reduction through to follow-up through remote questionnaires and assessment of health records at 1 year post-randomisation. 13. Average blood pressure and perceived side effects between groups through remote assessment of health records at 1 year post-randomisation. 14. Participants experiencing clinical events at long-term follow-up through remote assessment of health records at 3, 5, and 10 years post-randomisation (subject to further funding). 15. Participant attitudes towards deprescribing through remote questionnaire at 1 year post-randomisation 16. Initial and long-term cost-effectiveness of implementing deprescribing through remote questionnaires, assessment of health records, and extrapolation of trial outcomes encompassing 1 year post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactMelanie Carr
Outcome results
None listed