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    Summary
    EudraCT Number:2017-001270-41
    Sponsor's Protocol Code Number:CPRC2015/HSNORDOB-AUCHET/YB
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-001270-41
    A.3Full title of the trial
    Norepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study
    Etude noradrénaline seule ou en assiation avec la dobutamine dans le choc cardiogénique : étude randomisée, ouverte, en cross over de phase IV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Norepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study
    Etude noradrénaline seule ou en assiation avec la dobutamine dans le choc cardiogénique : étude randomisée, ouverte, en cross over de phase IV.
    A.3.2Name or abbreviated title of the trial where available
    HEARTSCHOCK-NORDOB
    A.4.1Sponsor's protocol code numberCPRC2015/HSNORDOB-AUCHET/YB
    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 SponsorCHRU NANCY
    B.1.3.4CountryFrance
    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 supportCHRU de Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Nancy
    B.5.2Functional name of contact pointDirection Recherche et Innovation
    B.5.3 Address:
    B.5.3.1Street AddressBâtiment Recherche - Rue du Morvan
    B.5.3.2Town/ cityVANDOEUVRE LES NANCY
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number33383 15 52 85
    B.5.5Fax number33383 15 74 51
    B.5.6E-mailrechclin-innov@chru-nancy.fr
    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 NORADRENALINE MYLAN
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameNORADRENALINE MYLAN
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    D.2.1.1.1Trade name Dobutamine
    D.2.1.1.2Name of the Marketing Authorisation holderPANPHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cardiogenic Shock
    Choc cardiogénique
    E.1.1.1Medical condition in easily understood language
    Cardiogenic Shock
    Choc cardiogénique
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Norepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study
    Etude Noradrénaline seule en association avec la Dobutamine dans le choc cardiogénique : Etude randomisee, ouverte, en cross over de phase IV. Heart SHOCK-NORDOB.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
    - To evaluate the dose and the admistration's kinetics of the treatments
    - To evaluate the dose and the admistration's kinetics of the treatments
    - Evaluation de l’efficacité des traitements sur les paramètres macro- et micro-circulatoires
    - Evaluation de la tolérance des traitements
    - Evaluation de la posologie et de la cinétique d’administration des catécholamines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with cardiogenic shock (ischemic, rythmic, valvular) defined by :
    - Cardiac index (CI) < 2,2 L/min/m² or CI < 2,5 L/min/m² under vasopressor/inotropic treatment
    - 0rgan hypoperfusion signs :
    a) mottles,
    b) capillary refill time greater or equal to 3 seconds ,
    c) urine output < 0,5 mL/kg/hour during at least one hour or renal replacement therapy,
    d) consciouness impairment,
    e) pulmonary oedema,
    f) hyperlactatemia (> 2 mmoL/L)

    - Mean arterial pressure > 65 mmHg under norepinephrine treatement

    - Patients with social coverage

    - Patient having given his / her consent, free, informed and in writing. If not, consent will be obtained from a family member / support person, if present. As soon as possible, the patient will be informed and his / her consent will be requested for the possible continuation of the research
    Patient avec choc cardiogénique défini par :
    - Index cardiaque (IC) < 2,2 l/min/m2 en l’absence de thérapeutique vasopressive ou inotrope ou IC<2,5l/min/m2 sous traitement inotrope/vasopresseur
    - Un des signes d’hypoperfusion tissulaire suivants :
    a. Présence de marbrures ;
    b. Temps de recoloration cutané ≥ 3 s ;
    c. Diurèse horaire < 0.5 ml/Kg pendant au moins une heure ou indication d’une épuration extrarénale ;
    d. Modification brutale de la conscience
    e. Œdème aigu du poumon
    f. Lactate augmenté (> 2mmol/L)

    - Pression artérielle moyenne supérieure à 65 mmHg sous noradrénaline.

    - Affiliation obligatoire à un régime de sécurité sociale

    - Patient ayant donné son consentement, libre, éclairé et par écrit. A défaut, le consentement sera obtenu auprès d’un membre de la famille/personne de confiance, s’il est présent. Dès que possible, le patient sera informé et son consentement lui sera demandé pour la poursuite éventuelle de la recherche
    E.4Principal exclusion criteria
    < 18 years old
    Pregnancy
    Inclusion in other drug study in cardiogenic shock , inclusion in study with medical device (for instance valve replacement)
    Poisonings with cardiotoxicants
    Patient with intra-aortic ballon pump, extracorporeal life support, ventricular support device
    Patient under guardianship
    Patient de moins de 18 ans
    Femme enceinte
    Patient inclus dans une autre étude de type médicament sur le choc cardiogénique ou de type dispositif médical (par exemple implantation de valve)
    Patient bénéficiant d’une contre pulsion par ballonnet intra-aortique et /ou d’une assistance circulatoire périphérique (ECMO)
    Patient sous tutelle, curatelle
    E.5 End points
    E.5.1Primary end point(s)
    Composite criteria for efficacy of treatment :
    - increase of cardiac index > 15%,
    - increase of organ perfusion assessed by :
    -lactate clearance > 15%,
    - decrease of mottling (decrease of 2 points of Mottling score),
    - increase of musculaire oxygen saturation measured by NIRS > 15%,
    - urine output 50%,
    - increase of SVcO2 > 15% ;
    and safety (occurence of side effects) :
    - increase of heart rate > 15% ,
    - increase of oxygen consumption evaluated by decrease of ratio mean arterial pressure / heart rate > 15% (Buffington ratio).

    The primary endpoint is defined by the presence of 2 efficacy criterias without any side effects.
    Critère composite d’efficacité :
    - amélioration de l’index cardiaque > 15%
    - amélioration de perfusion d’organe évaluée par :
    - clairance lactate > 10%
    - ou disparition des marbrures (baisse de deux unités du mottlingscore ; Intensive Care Med. 2011 May; 37(5):801-7)
    - ou augmentation de la saturation musculaire en 02 mesurée par NIRS > 15 %
    - ou augmentation diurèse > 50%
    - ou augmentation de la SVcO2 > 15%.
    et de sécurité :
    - sans les effets secondaires délétères suivants :
    - augmentation fréquence cardiaque > 15%
    - augmentation de la consommation d’oxygène du myocarde évaluée par la baisse > 15 % du rapport entre la pression artérielle moyenne (PAM) et la fréquence cardiaque (rapport de Buffington)

    Un critère de jugement principal positif correspond donc à la présence des deux critères d’efficacité et d’aucun des effets secondaires mentionnés dans le critère de sécurité.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospitalization in the resuscitation department.
    Pendant l'hospitalisation dans le service de réanimation.
    E.5.2Secondary end point(s)
    - Evaluation of efficacy by measure of heart rate, blood pressure, SVcO2, lactate clearance, muscular oxygen musculare, urine output, mottle
    - Evaluation of tolerance by measure of atrial and ventricular arythmia
    - Measure of catecholamines doses, time to reach the target
    - Evaluation de l’efficacité sur : la fréquence cardiaque, la pression artérielle, la SVcO2, la clairance du lactate, la saturation musculaire en O2, la diurèse, les marbrures.
    - Evaluation de la tolérance sur : les arythmies atriales et ventriculaires
    - Dose de catécholamine utilisée, durée pour atteindre les objectifs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During hospitalization in the resuscitation department.
    Pendant l'hospitalisation dans le service de réanimation.
    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 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 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) Yes
    E.8.2.2Placebo No
    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 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
    Last Visit of Last Patient
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 12
    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 No
    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 state42
    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
    Non applicable
    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 Decision2017-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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