RecruitingNAINTERVENTIONAL

pErsonalised Nocebo Assessment of Beta-blockEr Symptoms in Heart Failure

This study aims to understand why some people with heart failure stop taking beta-blocker medicines, even though these drugs are vital for their health. Often, patients stop due to symptoms they believe are side effects. However, sometimes these symptoms might be due to heart failure itself, or even the 'nocebo effect' – where worrying about side effects can actually make someone feel them. The study wants to check, for each individual, if their symptoms are genuinely caused by the beta-blocker or something else. By understanding this, we hope to help more people continue with these life-improving treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

150

Start

29 Apr 2025

Estimated completion

01 Dec 2027

Side-Effect Heart Failure

What is this study about?

Beta-blockers are a very important type of medicine for people with heart failure. They help people live longer and reduce the need for hospital trips. However, many people who start taking them later stop because they experience symptoms they believe are side effects of the medicine. This is a real problem because it means they miss out on treatment that could significantly improve their health.

This study wants to get to the bottom of why people stop these vital medicines. Sometimes, the symptoms are genuine side effects of the beta-blocker. But often, the same symptoms can happen even when someone isn't taking the beta-blocker, or when they're taking a 'dummy' pill (a placebo). These symptoms might be caused by the heart failure itself, or by something called the 'nocebo effect'. This means that if someone expects to have side effects, they might actually feel them, even if the medicine isn't causing them.

The main goal of this study is to find out, for each person, whether their symptoms are truly caused by the beta-blocker. We want to see how many of these symptoms are real side effects and how many are linked to worries or expectations. By clearly identifying what's causing the symptoms, we hope to help more people restart their beta-blocker treatment and continue to benefit from it.

Key takeaways

Heart failure medicines like beta-blockers are very important.
Many people stop beta-blockers due to perceived side effects.
This study investigates if symptoms are real side effects or from other causes like the 'nocebo effect'.
It uses a personalised approach for each participant.
The goal is to help more people safely restart beneficial treatment.
Participation involves taking different tablets and reporting symptoms via a phone app.

Who may be eligible?

This study is looking for adults who have heart failure where their heart's pumping ability is reduced (doctors call this an LVEF of less than 40%). You must have tried a beta-blocker medicine before for your heart failure, but stopped taking it because you (or your doctor) thought it was causing side effects. Crucially, you shouldn't be taking any beta-blockers right now.

There are also some reasons why you wouldn't be able to join. For example, if you've had a very bad allergic reaction to beta-blockers in the past, or if you have certain other serious health conditions like severe asthma, a very slow heartbeat, very low blood pressure, or some specific heart rhythm problems. Your doctor will carefully check your medical history to make sure taking part is 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.

Do you have heart failure with reduced pumping ability?
Have you stopped taking beta-blockers for heart failure because of 'side effects'?
Are you currently NOT taking any beta-blocker medicine?
Are you aged 18 or over?
Do you NOT have severe asthma or a very slow heart rate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last a total of 13 weeks. For the first two weeks, you'll take a beta-blocker tablet (bisoprolol 2.5mg) every day. Then, for the next nine weeks, things will be a bit different. You'll take tablets daily, but sometimes they will be the beta-blocker, sometimes a dummy pill (placebo), and sometimes you won't take any study tablet at all. The order of these nine weeks will be decided by chance, like drawing lots, and you and the study team won't know which tablet you're taking or if you're taking one.

Finally, for the last two weeks, you'll go back to taking the beta-blocker tablet daily. Throughout the study, you'll use a smartphone app daily to report how strong the main symptom was that made you stop your beta-blocker before. You'll also fill out a weekly survey about your general heart failure symptoms and your quality of life. At the end, you'll receive a personalised report explaining what the study found about your symptoms.

Potential risks and benefits

Taking part in this study could offer you a clearer understanding of your symptoms and whether they are truly linked to beta-blocker medication. This personalised information might help you feel more comfortable restarting a vital treatment for your heart failure. As with any medication, there's always a small chance of experiencing side effects from the beta-blocker, although you will be carefully monitored. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

Imperial College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'heart failure'?

Heart failure means your heart isn't pumping blood around your body as well as it should. It can make you feel tired and breathless.

What are 'beta-blockers'?

Beta-blockers are medicines that help your heart work more efficiently. For people with heart failure, they can improve how long you live and reduce hospital visits.

What is the 'nocebo effect'?

The nocebo effect is when you experience symptoms because you expect to have them, even if the medicine itself isn't causing them. It's the opposite of the 'placebo effect'.

What is a 'placebo'?

A placebo is a 'dummy' tablet that looks just like the real medicine but contains no active drug. It helps researchers understand how much of a medicine's effect is due to the drug itself.

Will I know if I'm taking the real medicine or the dummy pill?

For nine weeks of the study, neither you nor the doctors will know whether you are taking the beta-blocker, the dummy pill, or no tablet. This is called 'double-blinded' and helps make the results fairer.

How to find out more

Sameer Zaman, MBBS

sameer.zaman1@nhs.net 020 3313 1000 Official trial record

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