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    Summary
    EudraCT Number:2016-001437-27
    Sponsor's Protocol Code Number:P150801
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-02
    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 number2016-001437-27
    A.3Full title of the trial
    Efficacy of furosemide versus vascular filling in Patients with Acute Myocardial Infarction with Right Ventricular Extension: a multicentric randomized controlled trial.
    Efficacité du furosémide versus remplissage vasculaire dans l'infarctus inférieur avec extension au ventricule droit : un essai randomisé contrôlé multicentrique.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    FAMIE
    A.4.1Sponsor's protocol code numberP150801
    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 supportFondation Coeur & Recherche
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailmireille.toy-miou@aphp.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 Furosémide Renaudin
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Renaudin
    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 nameFurosémide Renaudin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFurosémide
    D.3.9.1CAS number C03CA01
    D.3.9.3Other descriptive nameFurosémide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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 Yes
    D.2.1.1.1Trade name Chlorure de sodium 0,9%
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE SA
    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 nameChlorure de sodium 0,9%
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChlorure de sodium
    D.3.9.1CAS number B05XA03
    D.3.9.3Other descriptive nameChlorure de sodium
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myocardial infarction with right ventricular extension.
    Patients ayant un infarctusv inférieur avec extension au ventricule droit
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    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 PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to demonstrate improved hemodynamic parameters in the short term in patients admitted for acute myocardial infarction with extension RV treated with furosemide.
    L'objectif principal est de démontrer l'amélioration des paramètres hémodynamiques à court terme chez des patients admis pour infarctus du myocarde aigu avec extension VD traités par furosémide.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    ­ Evaluate the efficacy (clinical benefit) of furosemide.
    ­ Observe the effect of treatments on improving cardiac index and diastolic function via an echography by Doppler method.
    ­ Compare the duration of hospitalization in intensive care.
    ­ Assess the safety of furosemide.
    ­ Assess the post-infarction survival at one month of hospitalization.
    Les objectifs secondaires sont :
    - D'évaluer l'efficacité (bénéfice clinique) du furosémide
    - D'observer l'effet des traitements sur l'amélioration de l'index cardiaque et de la fonction diastolique via une échographie par méthode Doppler.
    - De comparer la durée d'hospitalisation en soins intensifs.
    - D'évaluer la sécurité du furosémide.
    - D'évaluer la survie post-infarctus des patients à un mois de l'hospitalisation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ­ Age >18 years
    ­ Inferior acute myocardial infarction (<= D + 7)
    ­ Right ventricular extension defined by one following echocardiographic criteria :
    o Dilatation of the right ventricle (RV/LV area> 0.9)
    o RV dysfunction defined by TAPSE <16mm or S velocity <10cm.s-1
    o Akinesia or hypokinesia of two contiguous segments of the right ventricle
    o Decrease of pitch on lung failure flow <150ms
    - Inferior vena cava dilatation (>=20mm) and non-compliant (changes <50%) associated with one hemodynamic instability criteria :
    o Oliguria (diuresis <800mL/24h or 0.5mL/kg/min)
    o Systolic blood pressure <100mmHg
    o Oxygen saturation <91% on room air
    o Bradycardia (heart rate <60/min, not valid for patients on beta-blockers).
    ­ Informed consent for study participation signed.
    - Patient âgé de 18 ans et plus
    - Patient présentant un infarctus du myocarde de topographie inférieure récent (<= J+7) diagnostiqué depuis 48h maximum
    - Patient avec une extension au ventricule droit définie par un des critères échocardiographiques suivants :
    o Dilatation du ventricule droit (rapport des surfaces VD/VG>0.9)
    o Dysfonction VD (TAPSE<16mm ou onde S tricuspide <10cm.s-1)
    o Akinésie ou hypokinésie de deux segments contigus du ventricule droit
    o Pente de décroissance du flux d'insuffisance pulmonaire <150ms
    - Patient avec une dilatation de la veine cave inférieure (>=20mm) non compliante (variation <50%) avec un des signes de mauvaise tolérance hémodynamique suivants :
    o Oligurie (diurèse < 800mL/24h ou 0.5mL/kg/min)
    o Hypotension (pression artérielle systolique <100mmHg)
    o Dyspnée (saturation <91% en air ambiant)
    o Bradycardie (fréquence cardiaque <60/min sans bétabloquant).
    Ce critère d'inclusion ne pourra pas être utilisé pour les patients sous bétabloquants.
    ­ Patient informé et ayant signé le formulaire d'information et de consentement de participation à l'étude
    E.4Principal exclusion criteria
    - Minor and pregnant woman
    - Mechanical complications of myocardial infarct
    - Patients who received> 40mg diuretic /day during the last 15 days
    - Hypersensitivity to furosemide or any of its excipients
    - Aortic stenosis (area <1 cm² or mean gradient> 40mmHg), mitral or aortic regurgitation grade >=3
    - Severe left ventricular dysfunction defined by an LVEF <35%
    - Renal impairment defined by a serum creatinine> 200µmol / mL
    - Sodium and water retention
    - Urinary tract obstruction
    - Hypovolemia or dehydration
    - Severe hypokalemia (K + <3 mmol / L)
    - Severe hyponatremia (Na + <125 mmol / L)
    - Hepatitis ongoing, liver failure or hepatic encephalopathy
    - No affiliation to a social security scheme or other social protection scheme
    - Private Patient of liberty or under legal protection (guardianship, curatorship)
    - Inability or refusal to understand or refusal to sign the informed consent from study participation
    - Mineur et femme enceinte
    - Complications mécaniques de l'IDM (Communication Inter-Ventriculaire, tamponnade, rupture de paroi libre et rupture mitrale)
    - Patient ayant reçu > 40mg de diurétique/j au cours des 15 derniers jours
    - Hypersensibilité au furosémide ou à l'un de ses excipients
    - Présence d'une valvulopathie sévère : rétrécissement aortique serré (surface<1cm² et/ou gradient moyen>40mmHg), IM ou IA >=3/4
    - Dysfonction VG sévère définie par une FEVG<35%
    - Insuffisance rénale définie par une créatinémie >200µmol/mL
    - Rétention hydrosodée
    - Obstruction des voies urinaires
    - Hypovolémie ou déshydratation
    - Hypokaliémie sévère (K+ < 3 mmol/L)
    - Hyponatrémie sévère (Na+ < 125 mmol/L)
    - Hépatite en cours, insuffisance hépatique ou encéphalopathie hépatique
    - Non affiliation à un régime de sécurité sociale ou à un autre régime de protection sociale
    - Patient privé de liberté ou sous protection juridique (tutelle, curatelle)
    - Incapacité ou refus de comprendre ou refus de signer le consentement éclairé de participation à l'étude
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is compare the change in cardiac output in patients admitted and treated by either fluid expansion or furosemide.
    Le critère de jugement principal sera l'amélioration de l'index cardiaque (mesurée par méthode Doppler) définie par une augmentation de plus de 10% 24 heures après l'administration du traitement (H24-H30).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between H24-H30
    entre H24-H30
    E.5.2Secondary end point(s)
    Secondary endpoints will evaluate the safety and clinical benefit via:
    ­ Intra-hospital mortality
    ­ Rate of inotropic support
    ­ Hemodynamic instability requiring fluid expansion
    ­ Change in systolic blood at 24 hours
    ­ Change in heart rate at 24 hours
    ­ Urine output at 24 hours
    ­ The duration of hospitalization in intensive care
    ­ Hospitalizations for cardiovascular reason one month after acute myocardial infarction
    ­ One month mortality
    Les critères secondaires évalueront la sécurité et le bénéfice clinique via :
    - La mortalité intra hospitalière
    - La nécessité d'un support inotrope positif au cours de l'hospitalisation
    - La nécessité de recours au remplissage au cours de l'hospitalisation
    - La variation de la pression artérielle systolique à 24h
    - La variation de la fréquence cardiaque à 24h
    - La diurèse des 24h
    - La durée d'hospitalisation en USIC
    - Les ré-hospitalisations à un mois post-infarctus
    - La mortalité post-infarctus à un mois
    E.5.2.1Timepoint(s) of evaluation of this end point
    between H24 and 1 month
    entre H24 et 1 mois
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Remplissage vasculaire
    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 concerned4
    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 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
    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 months1
    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 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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state88
    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)
    Aucun
    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 Decision2016-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
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