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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2013-004322-28
    Sponsor's Protocol Code Number:P120910
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-09-25
    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 number2013-004322-28
    A.3Full title of the trial
    ReVAch : Test pharmacologique de réactivité vasculaire pulmonaire endothéliale dépendante à l'acétylcholine dans l'hypertension artérielle pulmonaire avec shunt cardiaque congénital de l'enfant et de l'adulte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ReVAch : Test pharmacologique de réactivité vasculaire pulmonaire endothéliale dépendante à l'acétylcholine dans l'hypertension artérielle pulmonaire avec shunt cardiaque congénital de l'enfant et de l'adulte
    A.3.2Name or abbreviated title of the trial where available
    REVACH
    A.4.1Sponsor's protocol code numberP120910
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 MIOCHOLE®
    D.2.1.1.2Name of the Marketing Authorisation holderDR GERHARD MANN CHEM-PHARM. FABRIK GMBH
    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 nameMIOCHOLE®
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNchlorydrate d'acétylcholine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 KRENOSIN
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENSIS FRANCE
    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 nameKRENOSIN
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdénosine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Patients (quelque soient leur âge) qui ont une cardiopathie avec shunt et qui ont une indication, en soin courant, d'une exploration hémodynamique par cathétérisme pour évaluation des résistances vasculaires pulmonaires en raison d'un doute sur l'opérabilité du patient sur les données cliniques et échocardiographiques usuelles.
    E.1.1.1Medical condition in easily understood language
    Patients atteinds d'un shunt cardiaque congénital
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10062326
    E.1.2Term Congenital cardiac septal defect
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation de la performance prédictive du test de réactivité vasculaire pulmonaire à l'acétylcholine sur la présence d'une HTAP évaluée à 1 an après la fermeture du shunt chez les patients opérés.
    E.2.2Secondary objectives of the trial
    - Tolérance du test pharmacologique
    - Comparaison de la distribution du test dans la population "shunt fermé " par rapport à la population " shunt non fermé "
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient, enfant (poids > 2Kg) ou adulte, (sans limite d'âge), qui présente une cardiopathie avec shunt
    - Patient qui nécessite, en soin courant, d'une exploration hémodynamique par cathétérisme droit pour évaluer les résistances vasculaires pulmonaires (en raison d'un doute sur l'opérabilité du patient sur les données cliniques et écho cardiographique usuels).
    - Consentement éclairé signé par le patient ou par les titulaires de l'autorité parentale et l'investigateur
    - Patient affilié ou bénéficiant d'un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Patients ayant un traitement spécifique de l'HTAP (les dérivés de la prostacyclines, les antagonistes des récepteurs de l'endothéline et les inhibiteurs de la phosphodiesterase 5).
    - Patient participant à une autre recherche avec période d'exclusion
    - Hypersensibilité connue à l'acéthycholine ou à l'adénosine
    - Contre-indication à l'utilisation de la Krenosin (Adénosine)
    - Bloc auriculoventriculaire du deuxième ou du troisième degré, à l'exception des patients porteurs d'un stimulateur cardiaque.
    - Dysfonctionnement sino-auriculaire (maladie de l'oreillette) à l'exception des patients porteurs d'un stimulateur cardiaque.
    - Bronchopneumopathies chroniques obstructives avec bronchospasme (ex : asthme bronchique).
    - Syndrome du QT long.
    - Hypotension artérielle sévère.
    - Patiente enceinte ou patiente en âge de procréer n'utilisant pas un moyen de contraception efficace.
    - Patiente enceinte ou patiente en âge de procréer n'utilisant pas un moyen de contraception efficace
    E.5 End points
    E.5.1Primary end point(s)
    - Performance prédictive du test de réactivité sur la survenue d'une hypertension artérielle pulmonaire, un an après la fermeture du shunt évaluée par l'aire sous la courbe ROC.

    Le test de réactivité est défini par la vitesse de flux en m/s sous vasodilatation endothélium dépendante par l'acétylcholine rapportée à la vitesse en m/s sous vasodilatation maximale (sous adénosine + monoxyde d'azote (NO) inhalé). Elle est mesurée par un des deux cathétériseurs du service.
    La présence ou non d'une hypertension artérielle pulmonaire un an après la fermeture du shunt dans la population " shunt fermé "sera évaluée par un cathétérisme cardiaque droit classique. A l'issue de cette démarche, le patient sera classé dans le groupe " hypertension pulmonaire " ou " pression pulmonaire normale " en aveugle de la connaissance du résultat du test de réactivité. Ce cathétérisme sera avancé si une HTAP est suspectée lors d'une échocardiographie réalisée en soin courant (vitesse tricuspide >2.8m/s).
    E.5.2Secondary end point(s)
    - Caractéristiques informationnelles du test de réactivité sur la survenue d'une hypertension pulmonaire. Détermination des couples de sensibilité-spécificité optimaux. Valeurs prédictives et rapport de vraisemblance positifs et négatifs pour les couples de sensibilité-spécificité optimaux.
    - Nature et fréquence des évènements indésirables, durée de procédure (min), durée de scopie (min), taux de procédures allant à son terme. Ces critères de tolérance seront collectés par le médecin responsable de salle et/ou le médecin coordonnateur de l'étude à l'aide d'un questionnaire présent dans le dossier de l'enfant,
    - Caractéristique de la distribution du test de réactivité dans la population " shunt non fermé " en comparaison avec la population " shunt fermé ".
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    cohorte patients shunt cardiaq
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months2
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state50
    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 Decision2013-12-03
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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    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.

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