[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595242":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":66,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":24,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Blinded bisoprolol tablets","EXPERIMENTAL","The protocol includes a randomised, blinded nine week phase in which participants take either bisoprolol, no tablets or placebo. They will be randomly assigned to take three weeks in total of blinded bisoprolol tablets.",[13],"Drug: Bisoprolol 2.5 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Blinded placebo","PLACEBO_COMPARATOR","Participants will be randomly assigned to take three weeks of blinded placebo tablets. They will be unaware as to whether they are consuming bisoprolol or placebo in this phase.",[19],"Drug: Placebo",{"label":21,"type":22,"description":23,"interventionNames":24},"No tablet","NO_INTERVENTION","There will be three weeks in total during the randomised phase in which patients do not consume any tablets.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DRUG","Bisoprolol 2.5 mg","Active bisoprolol 2.5mg tablets",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Placebo","Blinded placebo for a total of 3 weeks",[15],[36],{"name":37,"affiliation":38,"role":39},"Graham Cole, MB BChir","Imperial College NHS Trust","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},"Sameer Zaman, MBBS","CONTACT","020 3313 1000","sameer.zaman1@nhs.net",{"name":47,"role":43,"phone":44,"phoneExt":24,"email":48},"Amanpal Sidhu, MBChB","asidhu@ic.ac.uk",[50],{"facility":5,"status":51,"city":52,"state":24,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","London","W12 0HS","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-0.12574,51.50853,{"lat":60,"lon":59},[63,64,65],{"name":47,"role":43,"phone":44,"phoneExt":24,"email":48},{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},{"name":37,"role":39,"phone":24,"phoneExt":24,"email":24},{"type":67,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100595242","personalised-nocebo-assessment-of-beta-blocker-symptoms-in-heart-failure-100595242",false,"NCT07029906","pErsonalised Nocebo Assessment of Beta-blockEr Symptoms in Heart Failure","ENABLE-HF","Inclusion Criteria:\n\n* Heart failure with index LVEF \\\u003C40%\n* Not currently taking beta-blocker tablets\n* Previously tried one of beta-blocker tablet, and stopped taking it due to symptoms attributed to the beta-blocker\n* Consenting to participate in the study\n\nExclusion Criteria:\n\n* Documented anaphylaxis to beta-blockers\n* Clinical contraindication to Bisoprolol including (but not limited to):\n\n  1. Asthma requiring BTS treatment step 3 or higher\n  2. Marked bradycardia (\\\u003C50 bpm)\n  3. Symptomatic hypotension (systolic BP \\\u003C85mmHg)\n  4. Metabolic acidosis\n  5. Phaeochromocytoma\n  6. 1st degree heart block with PR interval \\>250ms\n  7. 2nd degree or complete heart block\n  8. Sick sinus syndrome\n  9. Acute pulmonary oedema\n* Life expectancy \\\u003C1 year\n* Patient refusal or inability to participate in the study","ALL","18 Years",{"count":78,"type":79},150,"ESTIMATED","INTERVENTIONAL",[82],"NA","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 this question reliably and with high precision requires a personalised approach with an 'N-of-1' study. This study will measure participants' symptoms in three scenarios: taking a beta-blocker tablet (bisoprolol 2.5mg) or a placebo tablet or no study medication in a randomised order.\n\nThe primary aim of this study is to determine, for an individual, whether the adverse effects of beta-blockade in heart failure are genuine. Specifically, the objectives are:\n\n1. To determine the proportion of a patient's symptoms that are due to taking beta-blocker tablets, and the proportion that are due to the expectation that the treatment will cause symptoms (the nocebo effect).\n2. To determine whether, on average, symptoms are worse when taking beta-blocker compared to placebo tablets or no treatment.\n3. To determine whether on average symptom intensity associated with beta-blockade decreases after receiving a report on how much of their symptoms are due to the beta-blocker.\n\nThroughout the protocol participants report daily the intensity of the symptom that previously led to their beta-blocker cessation via a smartphone app. Participants will report weekly their adherence, general heart failure symptoms and quality of life. In this way the investigators will discover, for an individual patient, the proportion of their symptom that is due to the beta-blocker tablet, and whether knowing their personalised results helps them to restart beta-blocker tablets.",[85,86],"Side-Effect","Heart Failure",[88,89,90,91,92,86],"Side-effect","Beta-blocker","Nocebo","Heart Failure Reduced Ejection Fraction","HFrEF","2025-06-17",{"date":95,"type":96},"2025-06-19","ACTUAL",{"date":98,"type":96},"2025-04-29",{"date":100,"type":79},"2027-12",{"name":5,"class":6},1]