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pErsonalised Nocebo Assessment of Beta-blockEr Symptoms in Heart Failure

RecruitingNAAges 18 Years - anyAllImperial College London
NCT07029906 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Beta-blocker tablets are an effective treatment for heart failure that make people live longer and reduce the need to be admitted to hospital. Many patients who are at high risk of death are prescribed beta-blockers, but later choose to stop taking them because of symptoms that they perceive to be side-effects. Some patients' symptoms may genuinely be side-effects due to the beta-blocker tablets, but, in reality, many of the symptoms which may lead to people stopping beta-blockers are actually experienced at similar rates compared to placebo. The symptoms may be caused by heart failure itself, or the expectation that they will have a side effect when they take a tablet (the nocebo effect). There is a need to be able to identify the majority of patients who aren't actually having side-effects so that they can restart beta-blockers and not miss out on life-prolonging treatment. To answer t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Heart failure with index LVEF \<40% * Not currently taking beta-blocker tablets * Previously tried one of beta-blocker tablet, and stopped taking it due to symptoms attributed to the beta-blocker * Consenting to participate in the study Exclusion Criteria: * Documented anaphylaxis to beta-blockers * Clinical contraindication to Bisoprolol including (but not limited to): 1. Asthma requiring BTS treatment step 3 or higher 2. Marked bradycardia (\<50 bpm) 3. Symptomatic hypotension (systolic BP \<85mmHg) 4. Metabolic acidosis 5. Phaeochromocytoma 6. 1st degree heart block with PR interval \>250ms 7. 2nd degree or complete heart block 8. Sick sinus syndrome 9. Acute pulmonary oedema * Life expectancy \<1 year * Patient refusal or inability to participate in the study
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What it tests

  • Bisoprolol 2.5 mg
  • Placebo
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Where

1 site
Imperial College London
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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