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    Summary
    EudraCT Number:2016-002367-34
    Sponsor's Protocol Code Number:29052016
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-16
    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 number2016-002367-34
    A.3Full title of the trial
    Beta 3 agonist treatment in heart failure (BEAT-HF II)
    Behandling med beta 3 agonist ved hjertesvigt (BEAT-HF II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Beta 3 agonist treatment in heart failure (BEAT-HF II)
    Behandling med beta 3 agonist ved hjertesvigt (BEAT-HF II)
    A.3.2Name or abbreviated title of the trial where available
    BEAT-HF II
    BEAT-HF II
    A.4.1Sponsor's protocol code number29052016
    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 SponsorHjertemedicinsk klinik, Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportHjerteforeningen (The Danish Heart Association)
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRigshospitalets Forskningspuljer (The research Council at Rigshospitalet )
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHjertemedicinsk afdeling, Rigshospitalet
    B.5.2Functional name of contact pointHenning Bundgaard
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityKøbenhavn Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535450512
    B.5.6E-mailhenning.bundgaard@regionh.dk
    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 Mirabegron "Betmiga" 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNMirabegron
    D.3.9.1CAS number 223673-61-8
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart Failure
    Hjertesvigt
    E.1.1.1Medical condition in easily understood language
    Heart failure
    Hjertesvigt
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    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 objective is to assess the effects of Mirabegron on left ventricular systolic function in patients with moderate to severe chronic heart failure.
    Formålet med studiet er at undersøge effekten af Mirabegron på venstre ventrikels systoliske funktion ved moderat til svær hjertesvigt.
    E.2.2Secondary objectives of the trial
    In patients with moderate to severe heart failure:
    1. Determine safety of administration of Mirabegron.
    2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodeling.
    3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test.
    4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias.
    5. Determine effects of Mirabegron on circulating biomarkers.
    6. Determine the immediate haemodynamic effects of Mirabron as measured invasively.
    Hos ateister med moderat til svær hjertesvigt:
    1. Undersøge sikkerheden af at bruge Mirabegron
    2. Undersøge om behandling med Mirabegron i 6 måneder medfører en gavnlig remodellering.
    3. Undersøge om Mirabegron forbedrer symptomer samt arbejdskapacitet bedømt ved 6 minutters gangtest.
    4. Undersøge MIrabegrons effekt på overledning, repolarisering, rytme og arytmier.
    5. Undersøge effekten af Mirabegron på cirkulerende biomarkører.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    BEAT-HF-II: Acute study – Study B.
    Date 12 June 2016
    The purpose of the invasive study is to characterize the acute hemodynamic effects including changes in cardiac output, pre- and after-load pressures and the expected lusitropic and inotropic effects at rest as well as during physical activity.
    BEAT-HF-II: Akut studie – Studie B.
    Dato: 12. juni 2016
    Formålet med den invasive undersøgelse er at karakterisere de akutte hæmodynamiske virkninger, herunder ændringer i hjertet minutvolumen, præ-og efter-load og den forventede lucitrope og inotrope effekter i hvile såvel som under fysisk aktivitet.
    E.3Principal inclusion criteria
    1. Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
    2. Left ventricular ejection fraction (LVEF) < 35% as assessed by cardiac CT
    3. Stable sinus rhythm (SR)
    4. On optimised evidence-based pharmacological HF treatment stable > 4 weeks with no current plan for changing HF therapy. The therapy must include a beta-blocker.
    5. No change in diuretics <4 weeks
    6. >18 years
    1. Stabil hjertesvigt NYHA-klasse II-III på iskæmisk eller ikke-iskæmisk basis
    2. LVEF <35% (CT-verificeret)
    3. Stabil sinusrytme
    4. På optimeret evidensbaseret farmakologisk HF behandling stabil > 4 uger uden aktuel plan om at ændre hjertesvigts-terapien. Behandlingen skal indeholde en beta-blokker.
    5. Ingen ændring i diuretika <4 uger
    6. ≥ 18 år
    E.4Principal exclusion criteria
    1. Acute myocardial infarction (AMI) or revascularisation < 3 month ago
    2. Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
    3. Uncorrected significant primary obstructive valve disease
    4. Planned major surgery including cardiac revascularisation
    5. Hemodynamically significant obstructive cardiomyopathy
    6. Acute myocarditis or constrictive pericarditis
    7. Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR< 40 ml/min/1,73 m2) diseases
    8. Heart failure due to uncorrected thyroid disease
    9. Cardiac mechanical support
    10. < 6 months after CRT
    11. Uncontrolled hypotension (defined as symptomatic systolic blood pressure < 90 mmHg) - or hypertension (defined as systolic at 180 mmHg or above and/or diastolic blood pressure at 110 mmHg or below)
    12. Unable to give informed consent
    13. Reduced compliance
    14. All women of child bearing potential will be required to use adequate contraception
    15. Pregnant or lactating women
    16. Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with digoxin (only applies to Study A).
    For exclusion from the CT part of the study
    - Known allergy to iodine containing contrast
    - Estimated GFR < 40 ml/min/1.73 m2
    Eksklusionskriterier
    1. AMI eller revaskularisering <3 måneder siden
    2. Atrieflimren (af tekniske årsager i forhold til billedbehandling og puls afrapportering)
    3. Ukorrigeret betydelig primær hjerte-klap-sygdom
    4. Planlagt større kirurgiske indgreb, herunder hjerte-revaskularisering
    5. Hæmodynamisk signifikant obstruktiv kardiomyopati
    6. Akut myocarditis eller konstriktiv pericarditis
    7. Klinisk signifikant lever-funktionsnedsættelse (defineret ved transaminaser eller bilirubin x 3 over øvre referenceniveau) eller klinisk signifikant nyre-funktionsnedsættelse (defineret ved GFR <30 ml/min/1, 73 m2)
    8. Hjertesvigt på grund af ukorrigeret sygdom i skjoldbruskkirtlen
    9. Hjerte-mekanisk understøtning
    10. <6 måneder efter anlæggelse af bi-ventrikulær pacemaker (CRT)
    11. Ukontrolleret hypo-eller hypertension
    12. Ude af stand til at afgive informeret samtykke
    13. Reduceret kompliance
    14. Alle kvinder i den fødedygtige alder, vil være forpligtet til at anvende sikker prævention
    15. Gravide eller ammende kvinder
    16. Behandling med et tricyklisk antidepressivum eller digoxin (fraset i studie B)

    For udelukkelse fra CT del af studiet:
    - Kendt allergi over for jod indeholdende kontrast
    - Anslået GFR <30 ml/min/1.73 m2
    E.5 End points
    E.5.1Primary end point(s)
    Increase in LVEF (measured by CT)

    -For acute study - Study B:
    • Changes in pulmonary capillary wedge pressure (PCWP) and cardiac output (CO) at the submaximal exercise intensity of 50 % of the maximal exercise capacity


    Stigning i LVEF (målt ved CT)

    -For acute study - Study B
    • Ændring i venstre ventrikels fyldningstryk (PCWP) og cardiac output (CO) ved submaximal arbejdsintensivitet (50% af max).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months

    For acute study B:
    After 2.5 hours
    Efter 6 måneders behandling

    For akut studie - studie B:
    Efter 2.5 time
    E.5.2Secondary end point(s)
    1) A reduction in NT proBNP,
    2) A reduction in Troponin I and troponin T,
    3) An increase in 6 min walking distance,
    4) Reduced admissions to hospital
    5) A reduced requirement for diuretics
    6) An increase in CO/SV,
    7) A reduction in LV diameters,
    8) An improvement in diastolic function,
    9) A reduction in LA volume,
    10) A shortening of the QT interval
    11) Improvement in functional class

    For acute study - Study B:
    • Cardiac index (CI) during submaximal exercise before and after Mirabegron administration
    • Pulmonary and systemic vascular resistance during exercise
    • Left ventricular end diastolic diameter during exercise
    • The change in mPAP (mean pulmonary artery pressure) from rest to submaximal exercise
    • The change in BNP, MR-ANP and copeptin from rest to submaximal exercise
    1. En reduktion i NT proBNP,
    2. En reduktion i Troponin T og Troponin I
    3. En stigning i 6 min. gangtest
    4. En reduktion i antallet af hospitalsindlæggelser
    5. En reduktion i forbrug af diuretika,
    6. En stigning i CO/SV
    7. En reduktion i venstre ventrikler diametre
    8. Forbedring af den diastoliske funktion
    9. En reduktion af LA volumen
    10. En afkortning af QT-intervallet
    11. Forbedring af funktionsklasse

    For akut studie - studie B:
    • Ændring i Cardiac index (CI) ved submaximal arbejdsintensivitet (50% af max).
    • Ændring i lungekar-modstanden (PVR)og I den systemiske kar-modstand (SVR) under arbejde
    • Ændring i venstre ventrikels end-diastoliske diameter under arbejde
    • Ændring i mPAP (mean pulmonary artery pressure) fra hvile til submaximalt arbejde
    • Ændringer i koncentrationer af BNP, MR-ANP og copeptin fra hvile til submaximalt arbejde
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 months

    For acute study B:
    After 2.5 hours
    Efter 6 måneders behandling

    For akut studie - studie B:
    Efter 2.5 time
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state70
    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)
    None
    Ingen
    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 Decision2016-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-21
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