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    Summary
    EudraCT Number:2016-000671-25
    Sponsor's Protocol Code Number:MK-1242-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-08-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000671-25
    A.3Full title of the trial
    A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi- Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)
    A.3.2Name or abbreviated title of the trial where available
    Vericiguat-Subjects With Heart Failure With Reduced Ejection Fraction
    A.4.1Sponsor's protocol code numberMK-1242-001
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Ltd
    B.5.2Functional name of contact pointMarie Pullen
    B.5.3 Address:
    B.5.3.1Street AddressHertford Road
    B.5.3.2Town/ cityHoddesdon, Hertfordshire
    B.5.3.3Post codeEN11 9BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044 7969 847981
    B.5.5Fax number0044 1992 705241
    B.5.6E-mailmarie.pullen@merck.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 No
    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 nameVericiguat
    D.3.2Product code MK-1242; BAY1021189
    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 INNVericiguat
    D.3.9.1CAS number 1350653-20-1
    D.3.9.2Current sponsor codeMK-1242
    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.IMP: 2
    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 No
    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 name Vericiguat
    D.3.2Product code MK-1242; BAY1021189
    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 INNVericiguat
    D.3.9.1CAS number 1350653-20-1
    D.3.9.2Current sponsor codeMK-1242
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    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 No
    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 nameVericiguat
    D.3.2Product code MK-1242; BAY1021189
    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 INNVericiguat
    D.3.9.1CAS number 1350653-20-1
    D.3.9.2Current sponsor codeMK-1242
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 2
    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
    Treatment of chronic heart failure with reduced ejection fraction (HFrEF)
    E.1.1.1Medical condition in easily understood language
    Treatment of chronic heart failure with reduced ejection fraction (HFrEF)
    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 10008908
    E.1.2Term Chronic 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
    To evaluate the efficacy of the oral soluble guanylate cyclase (sGC) stimulator MK-1242 (vericiguat) in comparison to placebo on a background of standard of care in increasing the time to first occurrence of the composite of CV death or HF hospitalization in subjects with HFrEF.
    E.2.2Secondary objectives of the trial
    In subjects with HFrEF on a background of standard of care:
    (1) To evaluate the efficacy of MK-1242 (vericiguat) in increasing the time to CV death in comparison to placebo.
    (2) To evaluate the efficacy of MK-1242 (vericiguat) in increasing the time to first HF hospitalization in comparison to placebo.
    (3) To evaluate the efficacy of MK-1242 (vericiguat) in increasing the time to total HF hospitalizations (first and recurrent) in comparison to placebo.
    (4) To evaluate the efficacy of MK-1242 (vericiguat) in increasing the time to the first occurrence of the composite of all-cause mortality or HF hospitalization in comparison to placebo.
    (5) To evaluate the efficacy of MK-1242 (vericiguat) in increasing the time to all-cause mortality in comparison to placebo.
    (6) To evaluate the safety and tolerability of MK-1242 (vericiguat).




    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    There will also be a separate imaging sub-study involving echocardiography and cardiovascular magnetic resonance (CMR), at participating sites. Consenting patients will participate, however participation in the imaging sub-studies is optional and does not impact participation in the main study. The imaging sub-study will be subject to a separate informed consent and ancillary document.
    E.3Principal inclusion criteria
    In order to be eligible for participation in this trial, the subject must:
    1. Provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
    2. Be male or female, aged 18 years or older on the day of signing informed consent.
    3. Have a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation.
    4. Have a previous HF hospitalization within 6 months prior to randomization or IV diuretic treatment for HF (without hospitalization) within 3 months prior to randomization.
    5. Have brain natriuretic peptide (BNP) or NT-proBNP levels within 30 days prior to randomization as follows:
    NT-proBNP BNP
    Sinus Rhythm > or = 1000 pg/mL > or = 300 pg/mL
    Atrial Fibrillation > or = 1600 pg/mL > or = 500 pg/mL
    6. Have a left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to randomization by any method (most recent measurement must be used to determine eligibility).
    7. Meet one of the following criteria:
    a) The subject is a male.
    b) The subject is a female who is not of reproductive potential, or who is of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug, by complying with acceptable methods of contraception.
    E.4Principal exclusion criteria
    The subject must be excluded from participating in the trial if the subject:
    1. Is clinically unstable at the time of randomization as defined by:
    a. Administration of any intravenous treatment within 24 hours prior to randomization, and/or
    b. Systolic blood pressure (SBP) <100 mmHg or symptomatic hypotension.
    2. Has concurrent or anticipated use of long-acting nitrates or NO donors including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine.
    3. Has concurrent use or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.
    4. Has concurrent use or anticipated use of a sGC stimulator such as riociguat.
    5. Has known allergy or sensitivity to any sGC stimulator.
    6. Is awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates receiving an implanted ventricular assist device.

    Cardiac Comorbidity
    7. Has primary valvular heart disease requiring surgery or intervention, or is within 3 months after valvular surgery or intervention.
    8. Has hypertrophic obstructive cardiomyopathy.
    9. Has acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy.
    10. Has post-heart transplant cardiomyopathy.
    11. Has tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
    12. Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI]) or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) within 60 days prior to randomization, or indication for coronary revascularization at time of randomization.
    13. Has symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days prior to randomization.
    14. Has complex congenital heart disease.
    15. Has active endocarditis or constrictive pericarditis.

    Non-cardiac comorbidity
    16. Has an estimated glomerular filtration rate (eGFR) calculated based on the Modification of Diet in Renal Disease (MDRD) equation <15 mL/min/1.73 m2 or chronic dialysis.
    17. Has severe hepatic insufficiency such as with hepatic encephalopathy.
    18. Has malignancy or other non-cardiac condition limiting life expectancy to <3 years.
    19. Requires continuous home oxygen for severe pulmonary disease.
    20. Has current alcohol and/or drug abuse.
    21. Has participated in another interventional clinical study and treatment with another investigational product ≤30 days prior to randomization or plans to participate in any other trial/investigation during the duration of this study.
    22. Has a mental or legal incapacitation and is unable to provide informed consent.
    23. Has a medical disorder, condition, or history thereof that in the opinion of the investigator would impair the subject’s ability to participate or complete the study.
    24. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
    25. Has Interstitial Lung Disease.
    26. Is breastfeeding or plans to breastfeed during the course of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the time-to first occurrence of the composite of CV death or HF hospitalization. This endpoint integrates the cause-specific components CV death and HF hospitalization and is the most frequently used primary endpoint in recent Phase III HFrEF trials. Subjects without a HF hospitalization or CV death at the time of analysis will be censored at the time of a non-CV death or time of last information available for subjects still alive at time of analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Effort will be made to follow-up subjects that prematurely stop study medication to collect at least information for the primary endpoint. The time point of final analysis will be based on number of CV deaths. In addition to the final analysis, an interim analysis for efficacy is planned at the time when approximately 75% of the planned number of CV death events are observed and the median follow up time is at least 10 months. At the interim analysis the primary composite endpoint of time to CV death or HF hospitalization and its component time to CV death will be tested. A futility analysis will be performed with the option to terminate the study early if it is determined at the time of analysis that the study is unlikely to demonstrate the efficacy of vericiguat on the primary endpoint
    E.5.2Secondary end point(s)
    The secondary study endpoints are:
    • Components of the primary composite endpoint:
    - Time to CV death
    - Time to first HF hospitalization
    • Time to total HF hospitalizations (first and recurrent)
    • Time to first occurrence of the composite of all-cause mortality or HF hospitalization
    • Time to all-cause mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analogous to the analysis of the primary endpoint, the analysis of the secondary efficacy endpoints will be performed under the intention to treat principle. All subjects randomized will be included in the analysis. Subjects will be analyzed as randomized.
    In addition to the final study analyses, at the efficacy interim analysis the primary endpoint and the secondary endpoint of time to CV death will be tested. The study can only be terminated early for success if both the primary endpoint and the CV death endpoint are statistically significant based on the pre-specified interim analysis boundaries.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Costa Rica
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Guatemala
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Peru
    Philippines
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Singapore
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    Venezuela, Bolivarian Republic of
    Vietnam
    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
    End of trial is defined as last subject’s last study-related phone call or visit.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days30
    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: 4000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 872
    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 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 state77
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 4872
    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)
    After a subject has ended his/her participation in the trial, it is expected they will continue to have their HF managed by physician, and have HF treatment following locally relevant guidelines such as ACCF/AHA and ESC Guidelines for the Management of Heart Failure recommendations applied individually at the discretion of the treating physician and in line with individual tolerability.
    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 Decision2016-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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