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    Summary
    EudraCT Number:2014-003273-42
    Sponsor's Protocol Code Number:14AOI11
    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:2015-06-29
    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 number2014-003273-42
    A.3Full title of the trial
    Comparing a diuretic vascular filling in the initial management of acute pulmonary embolism with right ventricular dysfunction normotensive
    Comparaison d’un traitement diurétique au remplissage vasculaire dans la prise en charge initiale de l’embolie pulmonaire grave normotensive avec dysfonction ventriculaire droite
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing a diuretic vascular filling in the initial management of acute pulmonary embolism with right ventricular dysfunction normotensive
    Comparaison d’un traitement diurétique au remplissage vasculaire dans la prise en charge initiale de l’embolie pulmonaire grave normotensive avec dysfonction ventriculaire droite
    A.4.1Sponsor's protocol code number14AOI11
    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 SponsorCHU de Nice
    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 supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointClinical Research Associate
    B.5.3 Address:
    B.5.3.1Street Address4 avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06000
    B.5.3.4CountryFrance
    B.5.4Telephone number0492034394
    B.5.5Fax number0492034011
    B.5.6E-mailmartinez.e@chu-nice.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
    D.2.1.1.2Name of the Marketing Authorisation holderFurosémide
    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 nameFurosemid
    D.3.2Product code 3400956401062
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 NaCl 9% isotonic
    D.2.1.1.2Name of the Marketing Authorisation holderNaCl 9% isotonic
    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 nameNaCl 9% isotonic
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    acute pulmonary embolism with right ventricular dysfunction normotensive
    Embolie pulmonaire grave normotensive avec dysfonction ventriculaire droite
    E.1.1.1Medical condition in easily understood language
    acute pulmonary embolism with right ventricular dysfunction normotensive
    Embolie pulmonaire grave normotensive avec dysfonction ventriculaire droite
    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 10050071
    E.1.2Term Embolism lung
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compared with the time of normalization of cTnI (biomarker of right ventricular dysfunction) in hospitalized patients in the initial phase of a serious EP normotensive between the 2 groups diuretic and vascular filling
    Comparaison du délai de normalisation de la troponine Ic (marqueur biologique de dysfonction ventriculaire droite), chez des patients hospitalisés à la phase initiale d’une EP grave normotensive, entre les 2 groupes diurétique et remplissage vasculaire
    E.2.2Secondary objectives of the trial
    • Compare the time of normalization of BNP between the 2 groups.
    • Compare the evolution of ultrasound parameters between the 2 groups right ventricular dysfunction.
    • Compare changes in clinical factors: Blood pressure (BP), heart rate, oxygen requirements and diuresis
    • Compare the occurrence of complications of severe pulmonary embolism:
    o State of cardiogenic shock
    o Need for thrombolysis
    o Need to use amines
    • Compare the occurrence of death from any cause and death related to PE between the 2 groups
    • Compare the occurrence of ischemic stroke or hemorrhagic
    • Compare the length of stay in intensive care
    To assess the safety of diuretic treatment
    • Comparer le délai de normalisation du BNP entre les 2 groupes.
    • Comparer l’évolution des paramètres échographiques de dysfonction ventriculaire droite entre les 2 groupes.
    • Comparer la variation des facteurs cliniques : Tension artérielle (TA), Fréquence cardiaque, besoins en oxygène et diurèse
    • Comparer la survenue des complications de l’embolie pulmonaire grave :
    o Etat de choc cardiogénique
    o Nécessité d’une thrombolyse
    o Nécessité de recours aux amines
    • Comparer la survenue des décès toutes causes et de décès reliés à l’EP entre les 2 groupes
    • Comparer la survenue d’accident vasculaire cérébral ischémique ou hémorragique
    • Comparer la durée du séjour en soins intensifs
    Evaluer la tolérance de l’administration d’un traitement diurétique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • older than 18 Patient
    • Hospitalized in the first 24 hours of a serious EP normotensive formally diagnosed (by a chest CT)
    The serious nature without hypotension is defined by the presence of:
    - From biological criteria: troponin and / or BNP positive
    AND
    - In sonographic criteria: dilated right ventricle defined by echocardiography right over left ventricle ratio (VG)> 0.9 in apical 4-chamber or 0.7 in large parasternal axis and right ventricular systolic dysfunction (TAPSE <16 mm and S 'pulsed TDI tricuspid <10 cm / sec) or pulmonary arterial hypertension (PAH) Pulmonary Arterial Pressure with systolic (PAPs)> 35 mmHg or paradoxical septum
    • Informed consent signed
    • Affiliation to social security
    • Patient âgé de plus de 18 ans
    • Hospitalisé dans les 24 premières heures d’une EP grave normotensive formellement diagnostiquée (par un angioscanner thoracique)
    Le caractère grave sans hypotension est défini par la présence:
    - De critères biologiques : troponine et/ou BNP positifs
    ET
    - De Critères échographiques : ventricule droit dilaté définie en échocardiographie par un rapport ventricule droit sur ventricule gauche (VG) > à 0.9 en coupe apicale 4 cavités ou 0.7 en coupe parasternale grand axe et dysfonction ventriculaire droite systolique (TAPSE < 16 mm et S’ en TDI pulsé tricuspidien < 10 cm / sec) ou HyperTension Artérielle Pulmonaire (HTAP) avec Pressions Artérielles Pulmonaires systoliques (PAPs) > 35 mmHg ou septum paradoxal
    • Consentement éclairé signé
    • Affiliation à la sécurité sociale
    E.4Principal exclusion criteria
    • Thrombolysis before inclusion
    • State of cardiogenic shock defined as systolic BP <90 mmHg or a drop of> 40 mmHg in systolic BP for> 15 minutes
    • severe chronic renal impairment defined by clearance <30 ml / min.
    • pregnant or nursing woman (a pregnancy test will be performed for women of childbearing age and the results will be communicated to the patient by a doctor of his choice)
    • Most People under guardianship
    • hospitalized without their consent and not protected by law No
    • Private person of liberty
    • Residence time of more than 24 hours in another department after the positive diagnosis of pulmonary embolism
    • Thrombolyse avant l’inclusion
    • Etat de choc cardiogénique définie par une TA systolique < 90 mmHg ou chute de > 40 mmHg de la TA systolique pendant > 15 minutes
    • Insuffisance rénale chronique sévère définie par clairance < 30 ml / min.
    • Femme enceinte ou allaitante (un test de grossesse sera réalisé pour les femmes en âge de procréer et les résultats seront communiqués à la patiente par un médecin de son choix)
    • Personne majeure sous tutelle ou curatelle
    • Personne hospitalisée sans son consentement et non protégée par la loi
    • Personne privée de liberté
    • Temps de séjour de plus de 24h dans un autre service après le diagnostic positif d’embolie pulmonaire
    E.5 End points
    E.5.1Primary end point(s)
    Time normalization hours Troponin Ic.
    This is a direct assay on peripheral venous sampling, easy to collect, accurate and reproducible, made ​​routines in biochemistry laboratories CHU Nice and Antibes CH. Assay kits are the same at the University Hospital of Nice and Antibes CH (BECKMANTM kit).
    The threshold of positivity of troponin is 0.07 ng / mL.
    Délai de normalisation en heures de la troponine Ic.
    Il s’agit d’un dosage direct sur prélèvement veineux périphérique, facile à recueillir, précis et reproductible, réalisé en routines dans les laboratoires de biochimie du CHU de Nice et du CH d’Antibes. Les kits de dosage sont les mêmes au CHU de Nice et au CH d’Antibes (kit BECKMANTM).
    Le seuil de positivité de la troponine est 0.07 ng / mL.

    E.5.1.1Timepoint(s) of evaluation of this end point
    inclusion to 108 hours (12h)
    inclusion à 108 heures (toutes les 12h)
    E.5.2Secondary end point(s)
    • Direct Determination of BNP, accurate, reproducible routinely performed in the laboratories of the University Hospital of Nice and Antibes CH whose positivity threshold of 100 pg / mL (Triage Kit BNPTM)
    • The right ventricular systolic function was assessed by ultrasound two commonly used parameters easily collected by transthoracic echocardiography: the TAPSE (Tricuspid Annular Plane Systolic Excursion) and peak velocity of the S wave to the side ring tricupide pulsed Doppler tissue . The threshold of normality is TAPSE> 16 mm [28]. The threshold of normality of the wave S tricuspid> 10 cm / second [28, 29]
    • ultrasound Other collected parameters: heart rate by measuring the right under ITV pulmonary pulsed Doppler pulmonary artery pressures with the flow of tricuspid insufficiency continuous doppler, dimensions in mm of the right ventricular apical four cavities and longitudinal deformation of right ventricle in speckle-tracking imaging (%).
    • Clinical factors identified in routine every 4 hours in intensive care units and intensive care: TA measured by automatic blood pressure, heart rate measured by scope, oxygen requirements identified on the sign constants and diuresis found on the sign constants.
    • Evaluation of the safety of diuretic treatment: serum potassium in mmol / l in the laboratory of Biochemistry and creatinine in mmol / l with estimating creatinine clearance by MDRD method ml / min biochemistry laboratory .
    • Complications of severe pulmonary embolism:
    o State cardiogenic shock defined by SBP <90 mmHg or a fall in BP> 40 mmHg lasting more than 15 minutes in the absence of other causes of shock (hypovolemic, septic or hemorrhagic)
    o Need for thrombolysis if occurrence of cardiogenic shock
    o Need for treatment with dobutamine if occurrence of cardiogenic shock with oliguria or TA maintained (defined as urine output <1 cc / kg / hour)
    • Other complications: death, ischemic stroke or hemorrhagic
    • Length of stay in intensive care unit: data collection from medical records
    • Monitoring 30 days (routine consultation)
    • Dosage du BNP direct, précis, reproductible réalisé en routine dans les laboratoires du CHU de Nice et du CH d’Antibes dont le seuil de positivité est de 100 pg / mL (Kit Triage BNPTM)
    • La fonction systolique ventriculaire droite échographique est estimée par 2 paramètres couramment utilisés faciles à recueillir en échographie cardiaque transthoracique : le TAPSE (Tricuspid Annular Plane Systolic Excursion) et pic de vélocité de l’onde S à l’anneau latéral tricupide en doppler pulsé tissulaire. Le seuil de normalité du TAPSE est > 16 à mm [28]. Le seuil de normalité de l’onde S tricuspidienne est > 10 cm/secondes [28, 29]
    • Autres paramètres échographiques recueillis : débit cardiaque droit par mesure de l’ITV sous pulmonaire en doppler pulsé, pressions artérielles pulmonaires avec le flux d’insuffisance tricuspidienne en doppler continu, dimensions du ventricule droit en mm en coupe apicale 4 cavités et déformation longitudinale du ventricule droit en speckle-tracking imaging (%).
    • Facteurs cliniques relevés en routine toutes les 4 heures dans les services de réanimation et soins intensifs : TA relevée par tensiomètre automatique, fréquence cardiaque relevée par scope, besoins en oxygène relevés sur la pancarte des constantes et diurèse relevée sur la pancarte des constantes.
    • Evaluation de la tolérance de l’administration d’un traitement diurétique : kaliémie en mmol / l au laboratoire de biochimie et créatinine en μmol / l avec estimation de la clairance de la créatinine par la méthode MDRD en ml / min au laboratoire de biochimie.
    • Complications de l’embolie pulmonaire grave :
    o Etat de choc cardiogénique défini par une TAS < 90 mmHg ou une chute de TA > 40 mmHg d’une durée de plus de 15 minutes en l’absence d’autre cause de choc (hypovolémique, septique ou hémorragique)
    o Nécessité d’une thrombolyse si survenue d’un état de choc cardiogénique
    o Nécessité d’un traitement par dobutamine si survenue d’un état de choc cardiogénique ou oligurie avec TA maintenue (définie par diurèse < 1 cc / kg / heure)
    • Autres complications : décès, accident vasculaire cérébral ischémique ou hémorragique
    • Durée de séjour en unité de soins intensifs : recueil des données à partir du dossier médical
    • Suivi à 30 jours (consultation de routine)
    E.5.2.1Timepoint(s) of evaluation of this end point
    inclusion to 108 hours (12h) for BNP
    inclusion to 108 hours (4h) for others parameters
    inclusion à 108 heures (toutes les 12h) pour le BNP
    inclusion à 108 heures (toutes les 4h) pour les autres critères
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned3
    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 the 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 months24
    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: 30
    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 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 state0
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    expected normal treatment of that condition
    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 Decision2014-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-09
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