ENABLE-HF ver1.0
Research type
Research Study
Full title
"pErsonalised Nocebo Assessment of Beta-bLockEr symptoms in Heart Failure" Are the adverse side effects of beta-blockade in heart failure genuine? An n-of-1 personalised assessment
IRAS ID
326227
Contact name
Graham D Cole
Contact email
Sponsor organisation
Research Governance and Integrity Team (RGIT), Imperial College London and ICHT
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
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.
REC name
London - Harrow Research Ethics Committee
REC reference
24/LO/0113
Date of REC Opinion
11 Mar 2024
REC opinion
Further Information Favourable Opinion