We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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.
Other forms of heart disease
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.
Heart failure (a problem with pumping function) is common and deadlier than most cancers. Beta-blockers dramatically increase lifespan, but many patients stop taking them because they experience symptoms after starting them that they or their healthcare professionals interpret as a side effect.
Studies in which patients start a beta-blocker or a dummy pill (without knowing which) show almost no difference in side-effects, suggesting that most symptoms are may not actually caused by beta-blockers. However, this has only ever been studied in groups, so an individual patient does not know whether their side effects are genuine.
In this project we will use a novel approach to studying heart failure patients as individuals. For the first time, we will equip patients with personalised information on how much of their side effects are due to the medication.
This can only be calculated using an n-of-1 study in which each patient receives randomly-ordered periods of (a) no tablet (b) placebo (“dummy”) tablet and (c) beta-blocker treatment. Patients will report how they feel daily and we will calculate, for individual patients, the symptom-difference between the treatment periods. We will provide patients with their own side effect information, before retrying beta-blockers. We will record how many continue taking it.
The information we collect will tell individual patients whether their symptoms are due to the beta-blocker, or due to a nocebo effect (expectation that the treatment will cause symptoms). We will develop communication techniques to convey this information to patients, so they can make informed decisions without relying on existing information obtained from studies of groups which may not be accurate for a given individual.
Developing new therapies for heart failure is difficult and expensive; this study aims to maximise usage of an already-demonstrated life-prolonging therapy by avoiding patients misinterpreting symptoms as being due to treatment.
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:
Observational type: Qualitative;
You can take part if:
You may not be able to take part if:
1. Having had a serious allergic reaction or genuine intolerance to beta-blockers 2. Having a clinical contraindication to Bisoprolol including (but not limited to): moderate/severe asthma, marked bradycardia (< 50), symptomatic hypotension (SBP< 85), metabolic acidosis, phaeochromocytoma, significant conduction disease (first degree heart block with PR> 250ms, second-degree or complete heart block), sick sinus syndrome, acute pulmonary oedema etc. 3. Being pregnant. 4. Life expectancy < 1 year. 5. Patient refusal to participate in the study.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by BRITISH HEART FOUNDATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 60884
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
