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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr James Sheppard
-
james.sheppard@phc.ox.ac.uk


Miss Melanie Carr
+44 1865 289311
optimise2-trial@phc.ox.ac.uk


Prof Richard McManus
-
R.McManus@bsms.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Optimising prescription of treatment in older patients with mild hypertension (high blood pressure) at increased risk of serious adverse events
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Optimising prescription of treatment in older patients with mild hypertension (high blood pressure) at increased risk of serious adverse events

Recruiting

Open to: All Genders

Age: Senior

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Medical Conditions

Hypertension

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The population of the UK is getting older and more people are living with multiple illnesses, taking lots of tablets to manage these illnesses. High blood pressure is one of the most common medical conditions in older people and many take two or more drugs to treat it.

Recent scientific studies suggest that large reductions in blood pressure, and too many drug prescriptions, may be associated with an increase in falls and death in older patients. We have previously undertaken a trial which showed that reducing the number of blood pressure lowering drugs prescribed to older people is safe in the short term (over a 3-month period). However, we do not know what the longer term effects of stopping blood pressure lowering drugs are. This trial aims to assess this in people aged 75 years or older, who have blood pressure in a normal range, are taking two or more medications and are at a higher risk of drug-related side-effects.

This trial will establish whether deprescribing common drugs that lower blood pressure is safe in older people. We will answer:
1. What is the effect of deprescribing blood pressure lowering drugs on hospital admissions and death?
2. Does deprescribing improve quality of life and/or save money for the NHS?

Building on our previous trial of 569 people, we will aim to enrol 3,014 participants aged 75 years or older who are taking blood pressure lowering drugs, but do not have raised blood pressure readings. We will actively follow them up for one year. We will focus on those who are frail and/or with a higher risk of serious drug related side-effects. We will examine whether deprescribing is safe in this group by measuring how many people are admitted to hospital or die the year after having blood pressure lowering drugs withdrawn compared to those who continued with them. If the numbers are similar, deprescribing will be viewed as safe. If safe, we will continue the trial and passively follow-up participants using their electronic health records for up to 10 years (subject to further funding). We will also check if deprescribing affects quality of life and/or costs for the NHS.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

10 Oct 2023 31 Dec 2025

Participants will be enrolled at participating practices in England by their own GP and be
required to attend a minimum of 2 appointments - a baseline assessment and one follow-up after 4 weeks. If further medications are to be stopped (for those in the intervention group) then another follow-up appointment would be required. After one year participants will be sent a questionnaire to complete remotely and the trial team will follow-up participants passively using their electronic health records for an average of 3 years (dependent on funding).


Those aged 75 years or older and taking 2 or more blood pressure lowering drugs, but who do not have raised blood pressure readings, may be eligible to participate.

You can take part if:



You may not be able to take part if:


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.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Benefits:
For those in the control group, there will be no clear additional benefits for taking part in the trial. For those in the intervention group who have their medication reduced, there is the possibility that they will be less likely to fall over, or suffer other side effects which could affect their quality of life. We will not know if this is the case until after the trial is finished.
Risks:
All participants will receive normal routine care from their GP, those in the control arm will be at no further risk by taking part. As medications which lower blood pressure also lower the risk of heart attack and stroke, those in the intervention arm may be at higher risk if their blood pressure was left unchecked. However, follow-up visits with their GP will be booked at 4 weeks following medication reduction (per medication removed) and if blood pressure is seen to rise significantly the medication will be restored rendering the likelihood of suffering an adverse event very low.
Risks are outlined in the patient information leaflet, as is a description of our data policy in order to reassure participants and provide clarity.
In order to reduce the burden of travel we have designed the study with as few visits as possible, with the majority of our outcome data being gathered remotely.

Miss Melanie Carr
+44 1865 289311
optimise2-trial@phc.ox.ac.uk


Dr James Sheppard
-
james.sheppard@phc.ox.ac.uk


Prof Richard McManus
-
R.McManus@bsms.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Oxford and funded by Health Technology Assessment Programme.



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Read full details for Trial ID: ISRCTN18030225

Or CPMS 56390

Last updated 19 December 2024

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