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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2020-005713-40
    Sponsor's Protocol Code Number:69HCL20_1135
    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:2021-05-27
    Trial results View 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 number2020-005713-40
    A.3Full title of the trial
    Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure patients on heart transplant waiting list: a multicenter, double-blind, randomized clinical trial.
    Effets de la dapagliflozine sur le syndrome cardio-rénal chez les patients atteints d'insuffisance cardiaque avancée inscrits sur liste d'attente pour une transplantation cardiaque : Étude clinique de phase II, randomisée, multicentrique, en double aveugle contre placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To assess the efficacy of oral treatment with dapagliflozin to reduce suPAR compared to placebo in advanced heart failure patients on heart transplant list at 6 months of follow-up.
    Évaluer l'efficacité du traitement oral par dapagliflozine pour réduire le taux sanguin de suPAR, en comparaison à un placebo, chez des patients atteints d’IC avancée en attente d’une transplantation cardiaque.
    A.3.2Name or abbreviated title of the trial where available
    ARCADIA-HF
    ARCADIA-HF
    A.4.1Sponsor's protocol code number69HCL20_1135
    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 SponsorHospices Civils de Lyon
    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 supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointRegulatory Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 QUAI DES CELESTINS
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number472406829+33
    B.5.5Fax number472115190+33
    B.5.6E-maildrci_promo@chu-lyon.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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    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
    for advanced Heart Failure patients on heart transplant waiting list
    pour les patients atteints d'insuffisance cardiaque avancée inscrits sur liste d'attente pour une transplantation cardiaque :
    E.1.1.1Medical condition in easily understood language
    For advanced Heart Failure patients on heart transplant waiting list
    pour les patients atteints d'insuffisance cardiaque avancée inscrits sur liste d'attente pour une transplantation cardiaque :
    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
    To assess the efficacy of oral treatment with dapagliflozin to reduce suPAR compared to placebo in advanced heart failure patients on heart transplant list at 6 months of follow-up.
    Évaluer l'efficacité du traitement oral par dapagliflozine pour réduire le taux sanguin de suPAR, en comparaison à un placebo, chez des patients atteints d’IC avancée en attente d’une transplantation cardiaque.
    E.2.2Secondary objectives of the trial
    To compare the following outcomes between the two groups (patients treated by dapagliflozin compared to patient received placebo):
    • Functional status at baseline and 6 months
    • The impact of dapagliflozin on hemodynamic parameters between baseline and 6 months
    • The impact of dapagliflozin on echocardiographic parameters between baseline and 6 months
    • Defined criteria associated with worsening cardio-renal syndrome during follow-up
    • Quality of life assessed at baseline and 6 months
    · Comparer les résultats suivants entre les deux groupes (traitement par dapagliflozine par rapport placebo) :
    · Statut fonctionnel évalué à la baseline et à 6 mois,
    · Impact de la dapagliflozine sur les paramètres hémodynamiques évalués à la baseline et à 6 mois,
    · Impact de la dapagliflozine sur les paramètres échocardiographiques évalués à la baseline et à 6 mois
    · Définir les paramètres associés à une dégradation du syndrome cardio rénal
    · Qualité de vie évaluée à la baseline et à 6 mois.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patient has signed informed consent form
    2) Age ≥ 18 years
    3) NYHA class ≥3
    4) LVEF ≤ 35%
    5) On optimal medical management (OMM) based on current heart failure practice guidelines at maximal tolerated dose for at least 30 days
    6) On waiting list for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months
    1) Obtention du consentement éclairé par écrit avant participation à l’étude
    2) Âge ≥ 18 ans
    3) Classe NYHA ≥3
    4) FEVG ≤ 35%
    5) Traitement de l’IC optimisé à la dose maximale tolérée selon les recommandations depuis au moins 30 jours
    6) Sur liste d'attente pour une transplantation cardiaque après décision de la « heart team » locale et qui ne serait pas en mesure de terminer de l’étude selon le jugement de l’investigateur (≥ 7 mois)
    E.4Principal exclusion criteria
    1) Priority patient on waiting list for heart transplantation
    2) Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
    3) Inotrope dependent, existence of ongoing mechanical circulatory support
    4) Current acute decompensated HF or hospitalization due to decompensated HF <30 days prior to the enrolment
    5) History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization
    6) Presence of an active, uncontrolled infection
    7) Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) < 60 days
    8) Glomerular filtration rate < 30 ml/min/1.73 m2, according to CKD-EPI formula
    9) Unstable or rapidly progressing renal disease
    10) Patients with severe hepatic impairment (Child-Pugh class C)
    11) Chronic treatment with dapagliflozin or other SGLT2 inhibitors
    12) Patient with known history of severe drug intolerance to dapagliflozin or any excipients of the dapagliflozin (galactose, lactase)
    13) Type 1 diabetes mellitus
    14) Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug at investigators’ discretion
    15) Participation in another clinical interventional trial
    16) Any condition other than heart failure that could limit survival to less than 24 months
    17) Positive pregnancy test if of childbearing potential or refusal to use adequate contraception or women breast-feeding
    18) Patients with any legal protection measure
    19) Patients without any health coverage
    20) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychological issues that are likely to impair compliance
    1) Patient prioritaire sur liste d'attente pour une transplantation cardiaque
    2) Insuffisance cardiaque due ou associée à une maladie thyroïdienne non corrigée, une cardiomyopathie obstructive, une maladie péricardique, une amylose ou une cardiomyopathie restrictive
    3) Patients inotrope-dépendants ou sous assistance circulatoire mécanique (ACM) continue au cours des 30 derniers jours,
    4) Episode de décompensation cardiaque aigue en cours ou hospitalisation pour une décompensation cardiaque <30 jours avant l’inclusion
    5) Antécédents de toute greffe d'organe ou implantation antérieure d'un dispositif d'assistance ventriculaire ou d'un dispositif similaire ou implantation planifiée après la randomisation
    6) Infection active, non contrôlée
    7) Intervention récente susceptible d'améliorer les symptômes d'insuffisance cardiaque (revascularisation coronaire, valvuloplastie mitrale percutanée, resynchronisation cardiaque) <60 jours
    8) Insuffisance rénale connue définie par un DFG <30 ml / min / 1,73 m2, selon la formule CKD-EPI
    9) Maladie rénale instable ou à évolution rapide
    10) Insuffisance hépatique sévère connue (Child-Pugh classe C)
    11) Traitement chronique à la dapagliflozine ou à un inhibiteur du SGLT2
    12) Intolérance sévère connue à la dapagliflozine ou à tout excipient de la dapagliflozine (galactose, lactase)
    13) Diabète de type 1
    14) Toute affection chirurgicale ou médicale qui pourrait significativement modifier l’absorption, la distribution, le métabolisme ou l’excrétion du médicament de l'étude à la discrétion des investigateurs
    15) Patient participant à une autre étude clinique interventionnelle
    16) Toute condition autre que l'insuffisance cardiaque qui pourrait limiter la survie à moins de 24 mois,
    17) Patientes actuellement enceintes ou allaitantes ou les femmes en âge de procréer n'utilisant pas de contraception efficace
    18) Patients sous mesure de protection juridique
    19) Patients non affilié à la sécurité sociale ou équivalent
    20) Maladie / trouble psychiatrique, dysfonctionnement cognitif irréversible ou problèmes psychosociaux susceptibles de nuire à l'observance
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change in soluble urokinase-type plasminogen activator receptor levels (ng/ml) between the baseline and 6 months of follow-up in both groups.
    Le critère de jugement principal sera la concentration sanguine de suPAR (ng / ml) évaluée à la baseline et à 6 mois dans les deux groupes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum 5 days before V2, M3 ± 3 d,M6 ± 7 d, M7 ± 14d
    Maximum 5 jours avant la visite 2, 3e mois ± 3 jours, 6e mois ± 7jours, 7e mois ± 14 jours
    E.5.2Secondary end point(s)
    Secondary endpoints of this study will be:
    • Functional status at baseline and 6 months assessed by :
    o VO2 max assessment
    • The impact of dapagliflozin on hemodynamic parameters between baseline and 6 months assessed by right heart catheterization hemodynamic parameters (cardiac output, pulmonary capillary wedge pressure, pulmonary artery systolic and mean pressure, right atrial pressure)
    • The impact of dapagliflozin on echocardiographic parameters between baseline and 6 months : LVEF, LVEDD, LVESV, mitral regurgitation grade, left atrial volume
    • Defined criteria associated with worsening cardio-renal syndrome during follow-up assessed by the levels of :
    o Nt-proBNP at baseline and at 6 months
    o Creatinine at baseline and at 6 months
    • Quality of life assessed at baseline and 6 months follow-up by :
    o Kansas City Cardiomyopathy Questionnaire (KCCQ)
    · Statut fonctionnel évalué à la baseline et à 6 mois :
    o VO2 max
    · Impact de la dapagliflozine sur les paramètres hémodynamiques évalués à la baseline et à 6 mois évalués par cathétérisme cardiaque droit : débit cardiaque, pression capillaire pulmonaire, pression artérielle pulmonaire systolique, pression artérielle pulmonaire moyenne, pression oreillette droite
    · Impact de la dapagliflozine sur les paramètres échocardiographiques évalués à la baseline et à 6 mois : FEVG, volumes télédiastolique et télésystolique du ventricule gauche insuffisance mitrale, volume de l’oreillette gauche
    · Définir les paramètres associés à une degradation du syndrome cardio renal évalués par les taux de :
    o Nt-proBNP à la baseline et à 6 mois
    o Créatinine à la baseline et à 6 mois
    · Qualité de vie évaluée à la baseline et à 6 mois :
    o questionnaire KCCQ.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits N° 1, 2, 3, 4 and 5
    Maximum 5 days before V2, D0, M3 ± 3 d,M6 ± 7 d, M7 ± 14d
    Maximum 5 jours avant la visite 2, J0, 3e mois ± 3 jours, 6e mois ± 7jours, 7e mois ± 14 jours
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 patient last visit
    dernier patient dernière visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days14
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state80
    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
    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 Decision2021-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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