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    Summary
    EudraCT Number:2015-001464-19
    Sponsor's Protocol Code Number:GE-122-020
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-05
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-001464-19
    A.3Full title of the trial
    AdreView™ Myocardial Imaging for Risk Evaluation – A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 25%≤LVEF≤35% ADMIRE-ICD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicentre trial to find out whether imaging can be used to see whether heart failure patients will benefit from a device to regulate their heart
    A.4.1Sponsor's protocol code numberGE-122-020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02656329
    A.5.4Other Identifiers
    Name:Health Canada Clinical Trials DatabaseNumber:HC6-24-C185975
    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 SponsorGE Healthcare Ltd. and its affiliates
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGE Healthcare Ltd. and its affiliates
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare Ltd.
    B.5.2Functional name of contact pointMedical Director - Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressThe Grove Centre, White Lion Road
    B.5.3.2Town/ cityAmersham, Buckinghamshire
    B.5.3.3Post codeHP7 9LL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailinfo@ge.com
    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 AdreView™
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameAdreView™
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[123I]iobenguane
    D.3.9.3Other descriptive nameIOBENGUANE 123I INJECTION FOR DIAGNOSTIC USE
    D.3.9.4EV Substance CodeSUB127285
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/ml millicurie(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart failure
    E.1.1.1Medical condition in easily understood language
    Heart failure
    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 10064081
    E.1.2Term Heart failure NYHA class III
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064080
    E.1.2Term Heart failure NYHA class II
    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
    To demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of ICD implantation in a population of New York Heart Association (NYHA) class II and III Heart Failure (HF) patients with 25%≤left ventricular ejection fraction (LVEF) ≤35%. This will be achieved by comparing allcause mortality observed in the AdreView™-guided therapy group to that observed in patients receiving the Standard of Care (SoC; defined as the medical care as recommended by internationally accepted HF guidelines), in whom no clinical decision will be made based upon AdreView™ scan results.
    E.2.2Secondary objectives of the trial
    Compare the rate of hospitalisation and death related to major complications of ICD implantation and a composite of the rate of complications of long-term device therapy in patients randomised to the AdreView group with a heart-to-mediastinal ratio (H/M) ≥1.6 with patients in the SoC group with H/M ≥1.6
    Compare AdreView-guided therapy to SoC therapy for:
    -occurrence of cardiac death
    -rate of hospitalisation for cardiovascular cause
    -rate of all-cause hospitalisation
    -composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest
    -occurrence of syncope.
    -clinical and healthcare resource utilisation data including ICD implantation, all hospitalisations, treatment of adverse events and AdreView administration
    Composite of the rate of hospitalisation and death related to major complications of device implantation and composite of the rate of complications of long-term device therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Patients ≥18 years of age at the time dated informed consent is obtained.
    (2) Female patients must be pre-menarchal, surgically sterile (had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or, if of childbearing potential, a serum or urine pregnancy test with the results known prior to AdreView™ (Iobenguane I123 Injection) administration is negative.
    (3) Patients willing and able to comply with all study procedures and a signed and dated informed consent is obtained before any study-procedure is carried out.
    (4) Heart failure NYHA class II or III for symptoms, patients with ischemic or nonischemic heart disease, eligible for ICD implantation as per each site’s standard of practice.
    (5) Non-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration receiving guideline-directed optimal medical therapy.
    (6) 25%≤LVEF≤35%, performed within 3 months before or at time of enrolment, as measured by radionuclide ventriculography, or electrocardiogram [ECG]-gated SPECT myocardial perfusion imaging [MPI], or magnetic resonance imaging [MR], computed tomography [CT], or 3D or 2D echocardiography [Simpson’s or multidisc method or equivalent only, M-mode echocardiography is not accepted].
    In case LVEF measurement is performed within 3 months before enrolment, measurement should be performed at least 40 days after a hospitalisation for HF or acute coronary syndrome (including myocardial infarction), and to be valid, method of measurement should be in accordance with the protocol and the imaging exam should be made available to the Sponsor in digital format.
    In case several valid LVEF measurements are available, the closest to enrolment will be used for inclusion determination.
    (7) Clinically stable HF in the medical judgment of the investigator (i.e., no significant changes in medication, no worsening of symptoms, no unscheduled visits to the doctor’s office) for the past 30 days and no hospitalisation for HF or acute coronary syndrome (including myocardial infarction) in the past 40 days.
    (8) Reasonable expectation of meaningful survival for at least 1 year.
    E.4Principal exclusion criteria
    (1) Patients with existing ICD or patient having an indication of ICD implantation for secondary prevention of SCD.
    (2) Hospitalisation for HF or for acute coronary syndrome in the previous 40 days.
    (3) Patients where a cardiac resynchronisation therapy (CRT) is planned or indicated
    (4) Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing).
    (5) NYHA class I or class IV symptoms at the time of study entry.
    (6) American College of Cardiology-American Heart Association (ACC-AHA) class III or class IV (unstable) angina.
    (7) Patient with chronic renal insufficiency defined as serum creatinine ≥3 mg/dl (or ≥265.2 μmol/L).
    (8) Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients in AdreView™ (Iobenguane I123 Injection).
    (9) Patient who is pregnant or plans to become pregnant within 2 weeks after AdreView™ (Iobenguane I123 Injection) administration.
    (10) Patient who has used any medication in the 2 weeks before AdreView™ (Iobenguane I123 Injection) that could interfere with the test: e.g., but not limited to amitriptyline or derivatives, imipramine or derivatives, other antidepressants or drugs known or suspected to inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines or cocaine.
    (11) Patients that have a medical condition that could interfere with the AdreView™ test (e.g., but not limited to left ventricular assist device, or prior heart transplant).
    (12) Patients who participated in a clinical study involving a drug or device within 30 days prior to study entry and patients participating in any other clinical study.
    (13) Patients having serious non-cardiac medical condition associated with significant elevation of plasma catecholamines, including pheochromocytoma.
    (14) Patients with a clinical diagnosis of (or being treated for) Parkinson’s disease or Multiple System Atrophy.
    (15) The patient has participated in a research study using ionizing radiation in the previous 12 months.
    (16) Patients previously randomized in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be all-cause mortality
    E.5.1.1Timepoint(s) of evaluation of this end point
    The duration of this study will be dependent on the time taken to achieve a total of 247 primary endpoint events in the randomised part of the study. The expected mean observational time per patient is 2.75 to 3 years
    E.5.2Secondary end point(s)
    - A composite of the rate of hospitalisation and death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery) and a composite of the rate of complications of long-term device therapy (i.e., infection not leading to hospitalisation, lead and/or generator removal/replacement, inappropriate shocks, explantation). (AdreView™ Low-risk group vs SoC H/M ≥1.6)
    - Cardiac death (composed of SCD, death due to cardiac arrhythmia, death due to HF, and death due to other cardiovascular causes)
    - The rate of hospitalisation for cardiovascular cause.
    - The rate of all-cause hospitalisation.
    - A composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachyarrhythmias, SCD and resuscitated cardiac arrest.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The duration of this study will be dependent on the time taken to achieve a total of 247 primary endpoint events in the randomised part of the study. The expected mean observational time per patient is 2.75 to 3 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Event-driven
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care cohort
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA110
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Slovakia
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 681
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-12-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1401
    F.4.2.2In the whole clinical trial 2001
    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)
    Standard care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-02-21
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