Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-004805-29
    Sponsor's Protocol Code Number:201200480529
    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:2013-05-28
    Trial 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 number2012-004805-29
    A.3Full title of the trial
    Beta 3 agonist treatment in heart failure
    (BEAT-HF)
    Beta 3 agonist treatment in heart failure
    (BEAT-HF)
    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)
    Beta 3 agonist treatment in heart failure
    (BEAT-HF)
    A.4.1Sponsor's protocol code number201200480529
    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 SponsorThe Heart Center, 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 supportThe Heart Center, Rigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Heart Center, Rigshospitalet
    B.5.2Functional name of contact pointThe Heart Center, Rigshospitalet
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4526112290
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    D.2.1.1.1Trade name The trial drug is from Astellas Pharma, Japan; A beta 3 adrenoceptor agonist - Mirabegron or Betanis
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 mg to 50 mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    Systolic heart failure
    Systolic heart failure
    E.1.1.1Medical condition in easily understood language
    Systolic heart failure
    Systolic 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 14.1
    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 if the study drug - Mirabegron - improves myocardial pump function in patients with heart failure

    Primary endpoint
    Increase in LVEF (measured by MRI or CT)
    The objective is to assess if the study drug - Mirabegron - improves myocardial pump function in patients with heart failure

    Primary endpoint
    Increase in LVEF (measured by MRI or CT)
    E.2.2Secondary objectives of the trial
    Secondary endpoints
    Combined endpoints including;
    1) A reduction in NT proBNP,
    2) An increase in 6 min walking distance,
    3) An increase in CO/SV,
    4) A reduction in LVIDd,
    5) An improvement in diastolic function,
    6) A reduction in LA volume,
    7) An increase in LVEF,
    8) A shortening of the QT interval
    9) Improvement in quality of life
    10) Improvement in functional class
    Secondary endpoints
    Combined endpoints including;
    1) A reduction in NT proBNP,
    2) An increase in 6 min walking distance,
    3) An increase in CO/SV,
    4) A reduction in LVIDd,
    5) An improvement in diastolic function,
    6) A reduction in LA volume,
    7) An increase in LVEF,
    8) A shortening of the QT interval
    9) Improvement in quality of life
    10) Improvement in functional class
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
    2. Left ventricular ejection fraction (LVEF) < 40%
    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
    Inclusion criteria
    1. Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
    2. Left ventricular ejection fraction (LVEF) < 40%
    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
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Unstable cardiac condition
    2. Acute myocardial infarction (AMI) or revascularisation < 3 month ago
    3. Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
    4. Uncorrected significant primary obstructive valve disease
    5. Planned major surgery including cardiac revascularisation
    6. Hemodynamically significant obstructive cardiomyopathy
    7. Stroke with significant neurological deficit
    8. Acute myocarditis or constrictive pericarditis
    9. Symptomatic bradycardia or > 1. degree AV-block unless the patient has a pacemaker
    10. Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR< 50 ml/min/1,73 m2) diseases
    11. Heart failure due to uncorrected thyroid disease
    12. Cardiac mechanical support
    13. < 6 months after CRT
    14. 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)
    15. Body mass index (BMI) > 35
    16. Unable to give informed consent
    17. Reduced compliance
    18. All women of child bearing potential will be required to use adequate contraception
    19. Pregnant or lactating women
    20. Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with dig
    Exclusion criteria
    1. Unstable cardiac condition
    2. Acute myocardial infarction (AMI) or revascularisation < 3 month ago
    3. Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
    4. Uncorrected significant primary obstructive valve disease
    5. Planned major surgery including cardiac revascularisation
    6. Hemodynamically significant obstructive cardiomyopathy
    7. Stroke with significant neurological deficit
    8. Acute myocarditis or constrictive pericarditis
    9. Symptomatic bradycardia or > 1. degree AV-block unless the patient has a pacemaker
    10. Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR< 50 ml/min/1,73 m2) diseases
    11. Heart failure due to uncorrected thyroid disease
    12. Cardiac mechanical support
    13. < 6 months after CRT
    14. 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)
    15. Body mass index (BMI) > 35
    16. Unable to give informed consent
    17. Reduced compliance
    18. All women of child bearing potential will be required to use adequate contraception
    19. Pregnant or lactating women
    20. Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with dig
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    Increase in LVEF (measured by MRI or CT)
    Primary endpoint
    Increase in LVEF (measured by MRI or CT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 26 weeks treatment
    After 26 weeks treatment
    E.5.2Secondary end point(s)
    Secondary endpoints
    Combined endpoints including;
    1) A reduction in NT proBNP,
    2) An increase in 6 min walking distance,
    3) An increase in CO/SV,
    4) A reduction in LVIDd,
    5) An improvement in diastolic function,
    6) A reduction in LA volume,
    7) An increase in LVEF,
    8) A shortening of the QT interval
    9) Improvement in quality of life
    10) Improvement in functional class
    Secondary endpoints
    Combined endpoints including;
    1) A reduction in NT proBNP,
    2) An increase in 6 min walking distance,
    3) An increase in CO/SV,
    4) A reduction in LVIDd,
    5) An improvement in diastolic function,
    6) A reduction in LA volume,
    7) An increase in LVEF,
    8) A shortening of the QT interval
    9) Improvement in quality of life
    10) Improvement in functional class
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 26 weeks treatment
    After 26 weeks treatment
    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 No
    E.6.5Efficacy No
    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 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 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 concerned2
    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 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
    Australia
    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
    The trial ends with the last visit of the last included patient or prematurely if definitions for early treatment as stated in the protocol are reached.
    The trial ends with the last visit of the last included patient or prematurely if definitions for early treatment as stated in the protocol are reached.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) No
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 70
    F.4.2.2In the whole clinical trial 85
    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
    Noen
    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 Decision2013-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-25
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 12:00:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA