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    Summary
    EudraCT Number:2017-002443-15
    Sponsor's Protocol Code Number:ICAF-BETA
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-09-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-002443-15
    A.3Full title of the trial
    Improving cardiac function in high-risk surgical patients: exercise testing, biomarkers and beta-blockade
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Improving heart functioning in high-risk surgical patients
    A.3.2Name or abbreviated title of the trial where available
    ICAF - BETA
    A.4.1Sponsor's protocol code numberICAF-BETA
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN95679074
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorYork Teaching Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportElsie May Skyes Charitable Funds
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationYork Teaching Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointMs Mia Porteous
    B.5.3 Address:
    B.5.3.1Street AddressWigginton Road
    B.5.3.2Town/ cityYork
    B.5.3.3Post codeYO31 8HE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01904725129
    B.5.6E-mailmia.porteous@york.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bisoprolol
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBisoprolol
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBisoprolol Fumarate
    D.3.9.1CAS number 66722-44-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Impaired VE/CO2 on cardio pulmonary exercise testing
    E.1.1.1Medical condition in easily understood language
    impaired cardiac function
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10007648
    E.1.2Term Cardiovascular disease, unspecified
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study objective is to assess the effect of bisoprolol on heart function in high-risk surgical patients through assessment of exercise testing and a reduction in VE/VCO2
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effect of bisoprolol on heart function in high-risk surgical patients through assessment of anaerobic threshold and evidence of heart abnormality.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 55 years or over
    - Scheduled for major intra-abdominal surgery
    - Presenting for routine CPET as part of pre-assessment
    - Not currently taking any BB medication and not taken BB medication within 1 month prior
    - Consent to GP being informed
    - VE/VCO2 greater than 34 on CPET, as either the value measured at VO2@AT, or the lowest measured value, plus at least one of the following:
    - Presence of a known history of a clinical risk factor for major adverse cardiac events (MACE) after surgery
     Ischaemic heart disease
     Cerebrovascular disease
     Renal insufficiency (creatinine > 170 mol.L-1)
     Chronic heart failure

    - Evidence of abnormal myocardial response on exercise testing
    - Flattened or inflecting oxygen uptake to heart rate response (oxygen pulse response, VO2/HR, panel 2)
    - Flattened or inflecting oxygen uptake to work rate response (VO2/Watt, panel 3)
    - Anaerobic threshold <11mls/kg/min
    E.4Principal exclusion criteria
    - Refusal or unable to give informed consent
    - Fewer than 7 days before scheduled surgery at pre-assessment appointment surgery
    - Current Beta blocker medication or having taken any Beta blocker within 1 month prior
    - Contra-indications to BB medication including:
    o bronchial asthma
    o reversible airways disease
    o decompensated heart failure (NYHA class IV)
    o fluid overloaded
    o hypotensive
    o severe liver impairment
    o second or third degree A-V block (unless pacemaker fitted)
    o SA block
    o sick sinus syndrome (unless pacemaker inserted)
    o cardiogenic shock
    o bradycardia (heart rate less than 60 bpm)
    o Prinzmetal's angina
    o Untreated Phaeochromocytoma
    o metabolic acidosis
    o poor blood circulation in the hands and feet
    o severe peripheral arterial insufficiency
    o known hypersensitivity to bisoprolol or its ingredients (lactose monohydrate, silica colloidal anhydrous, crospovidone (Type A), crospovidone (Type B), povidone 30, sucrose, magnesium stearate)
    o co-prescription with negative chronotropic agents such as digoxin, diltiazem, verapamil, amiodarone
    o co-prescription with medications that affect the plasma concentrations of bisoprolol such as rifampin, cimetidine, quinidine, fluoxetine, paroxetine, propafenone, digoxin, reserpine, monoamine oxidase inhibitors, clonidine
    E.5 End points
    E.5.1Primary end point(s)
    The effect on the ventilator equivalent for CO2 (VE/VCO2) as measured at anaerobic threshold or nadir, after introduction of beta-blockade
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the primary end point can be made after the last patient has had their second measurement of their ventilator equivalent for CO2 (VE/VCO2)
    E.5.2Secondary end point(s)

    1. Anaerobic threshold pre- and post-bisoprolol
    2. Evidence of myocardial abnormality on CPET (VO2/HR response, VO2/Watt response) pre- and post-bisoprolol
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of the secondary end points can be made after the last patient has had their second measurement of the above measures.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be when the last patient has had their second CPET performed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The decision as to whether to continue bisoprolol and at what dose will be a clinical decision made by the cardiology team after the repeat CPET has been undertaken.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-04-01
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