Personalised testing to find out if beta-blocker symptoms in heart failure are real or nocebo
Official title: pErsonalised Nocebo Assessment of Beta-blockEr Symptoms in Heart Failure
Run by Imperial College London · NCT07029906 · Data updated 2026-11-12
This project will test a personalised sequence of low-dose bisoprolol, matched placebo, and no-pill weeks to see if people with HFrEF who stopped beta-blockers are experiencing true drug side effects or expected nocebo symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT07029906 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with HFrEF (LVEF <40%) who are not currently taking a beta‑blocker because they previously stopped it due to perceived side effects and who have no contraindications to bisoprolol are ideal candidates.
✕Probably not a fit
People with clear contraindications to beta‑blockers (for example severe asthma, marked bradycardia or high‑grade heart block), very limited life expectancy, or who cannot participate in the dosing and follow‑up schedule are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ENABLE-HF is a prospective, randomised N-of-1 design enrolling people with HFrEF (LVEF <40%) who previously stopped a beta-blocker because of perceived symptoms. After screening, participants complete a two-week open-label run-in of bisoprolol 2.5 mg, followed by a nine-week double-blind phase of three randomized weeks each of bisoprolol 2.5 mg, matched placebo, and no tablet, and finish with a two-week open-label bisoprolol period. Medication packs and a smartphone (if needed) are provided and weekly symptom data are collected during each phase. The design aims to compare symptom rates within each participant to determine whether symptoms recur on active drug but not on placebo or no-pill weeks.
Why it matters
Potential benefit: If successful, the approach could help many patients restart life‑prolonging beta‑blocker therapy by distinguishing true side effects from nocebo or disease‑related symptoms.
How similar studies have gone: Placebo‑controlled work has shown many perceived beta‑blocker symptoms occur at similar rates on placebo, and N‑of‑1 approaches have been used in other nocebo and symptom contexts, but this personalised protocol for HFrEF is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Imperial College London
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Graham Cole, MB BChir — Imperial College NHS Trust
- Study coordinator: Sameer Zaman, MBBS
- Email: sameer.zaman1@nhs.net
- Phone: 020 3313 1000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.