RecruitingPhase IVInterventional

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

Many older adults take several daily tablets to manage their blood pressure. However, having blood pressure that drops too low can lead to dizzy spells, fainting, and dangerous falls. The OPTIMISE2 study, led by the University of Oxford and funded by the NHS, aims to find out if older people can safely take fewer blood pressure tablets. The trial involves over 3,000 participants aged 75 or older whose blood pressure is currently well controlled. Half will continue their normal medicines, while the other half will reduce one or more tablets with their GP's guidance. Doctors will monitor everyone closely to make sure their blood pressure stays in a safe range. Researchers will follow participants for at least a year to see whether reducing tablets improves daily life, avoids medication side effects, and prevents hospital visits.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

University of Oxford

Enrolment target

3,014

Start

10 Oct 2023

Estimated completion

31 Oct 2026

Hypertension

What is this study about?

As people grow older, it is very common to take multiple tablets every day. While medicines for high blood pressure help protect against heart attacks and strokes, taking too many can sometimes cause harm. In older adults, strong blood pressure treatments can cause readings to drop too low, especially when standing up. This can lead to lightheadedness, unsteadiness, and serious falls.

The OPTIMISE2 study is designed to find out whether older patients can safely reduce their blood pressure tablets under careful medical supervision. An earlier, smaller study showed that lowering medication was safe for at least three months. This larger trial will see what happens over a whole year and beyond, checking if taking fewer tablets helps people stay out of hospital and enjoy a better quality of life.

The study is taking place across roughly 200 GP surgeries in England. By comparing people who reduce their tablets with those who stay on their usual treatment, doctors hope to learn the safest way to manage blood pressure in later life without overmedicating.

Key takeaways

The study tests whether people aged 75 and older can safely take fewer blood pressure tablets.
The aim is to reduce problems like dizziness, fainting, and falls while keeping blood pressure safe.
Half of the participants will reduce a tablet, while the other half will stay on their normal medicines.
Care takes place locally at participating GP surgeries across England with very few extra visits.
Your blood pressure will be checked carefully, and tablets can be restarted immediately if needed.

Who may be eligible?

You may be able to join this study if you are 75 years of age or older and have been taking two or more blood pressure tablets for at least a year. Your blood pressure must currently be well controlled, meaning it is not unusually high. The trial specifically looks to help people who are living with mild frailty or who might be at a higher risk of dizzy spells, fainting, or falls.

You will not be able to participate if you have certain specific types of heart failure where your blood pressure tablets are needed to keep your heart working properly. Your GP will check your medical records to ensure that altering your medication is completely safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 75 or older.
I take two or more daily tablets to lower my blood pressure.
I have been on a steady dose of these medicines for at least four weeks.
My blood pressure is currently in a normal, controlled range.
I am registered at an English GP surgery taking part in the trial.

Answer every question to see your result.

What does participation involve?

Taking part is designed to be simple and works alongside your normal GP care. You will attend an initial appointment at your local surgery to check your blood pressure and discuss your tablets. If you are placed in the group that reduces medication, you will have a follow-up check after four weeks to make sure your blood pressure remains at a safe level. If another tablet is later reduced, an additional check will be arranged. After one year, you will be asked to fill in a short questionnaire at home about your health. The research team will then track your general health through your NHS electronic records for up to three years, meaning you do not need to make regular hospital visits.

Potential risks and benefits

If you are in the group that reduces medication, you may benefit from fewer side effects, such as feeling less dizzy, which could lower your risk of having a fall. However, there is a small chance your blood pressure could rise once a tablet is stopped. To keep you safe, your GP will check your readings four weeks after any change, and your original tablet will be restarted straight away if your blood pressure climbs too high. Joining the study is entirely your choice, and you can withdraw or return to your usual tablets at any time without it affecting your everyday NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

All Research Delivery Networks in England
City only
-, England

Common questions

Will stopping a tablet increase my risk of a stroke or heart attack?

Your GP will only reduce a medicine if your blood pressure is well controlled. You will be monitored closely, and if your readings rise significantly, your medicine will be restarted right away to keep you protected.

Can I choose whether to reduce my tablets or stay on them?

No. A computer randomly decides whether you reduce a tablet or keep taking your usual medicines. This is the fairest way to see if reducing medication is safe and helpful.

Do I need to travel to a hospital for this trial?

No. All appointments take place at your usual GP surgery, and later follow-ups are done using short questionnaires and your routine health records.

What happens if I start feeling unwell or dizzy?

You can contact your GP surgery at any point. If your doctor feels that changing your medication was the cause, they can quickly adjust or restart your previous tablets.

What if I change my mind after joining?

You are free to leave the study at any time. You do not need to give a reason, and your regular doctor's care will continue as normal.

How to find out more

Melanie Carr

optimise2-trial@phc.ox.ac.uk +44 1865 289311 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.