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    Summary
    EudraCT Number:2015-004497-15
    Sponsor's Protocol Code Number:ERGO
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004497-15
    A.3Full title of the trial
    Study on New Insights in Remodeling of Endocrine Cardiomyopathies: Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in Cushing’s Syndrome-Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs
    Nuove Intuizioni sul Rimodellamento nelle cardiomiopatie endocrine: Valutazione Intramiocardica, Molecolare e Neuroendocrina in risposta all'Inibizione Cronica della GMP Ciclico-Fosfodiesterasi 5A nella Sindrome di Cushing –cardiomiopatia Endocrina nella sindrome di cushing: Risposta ai GMP ciclico PDE5 inibitOri
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs
    cardiomiopatia Endocrina nella sindrome di cushing: Risposta ai GMP ciclico PDE5 inibitOri
    A.3.2Name or abbreviated title of the trial where available
    Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs
    cardiomiopatia Endocrina nella sindrome di cushing: Risposta ai GMP ciclico PDE5 inibitOri
    A.4.1Sponsor's protocol code numberERGO
    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 SponsorUMBERTO I - POLICLINICO DI ROMA
    B.1.3.4CountryItaly
    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 supportFondi di ricerca propri
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniv Sapienza/Azienda Policlinico Umberto I
    B.5.2Functional name of contact pointDip. Medicina Sperimentale
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico, 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number0649970540
    B.5.5Fax number0649970598
    B.5.6E-mailelisa.giannetta@uniroma1.it
    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 CIALIS - 20 MG 2 COMPRESSE RIVESTITE CON FILM IN BLISTER USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTadalafil
    D.3.4Pharmaceutical form 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 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
    Cushing’s Syndrome
    Sindrome di Cushing
    E.1.1.1Medical condition in easily understood language
    Cushing’s Syndrome
    Sindrome di Cushing
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011652
    E.1.2Term Cushing's syndrome
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The Primary Objective is to evaluate the effects of PDE5Ai on LV torsion angle as kinetic parameter of cardiac remodeling, measured at cine cardiac magnetic resonance (CMR) with tagging technique and contrast-enhanced in patients with CS cardiomyopathy
    Valutazione degli effetti dei PDE5i sull'angolo di torsione del ventricolo sinistro come parametro cinetico del rimodellamento cardiaco misurato alla cine Risonanza Magnetica cardiaca con tecnica tagging e mezzo di contrasto in pazienti affetti da Sindrome di Cushing
    E.2.2Secondary objectives of the trial
    - Measurement of the effect of PDE5Ai on LV strain at CMR with tagging at baseline and after PDE5Ai administration
    - Measurement of the effect of PDE5Ai on other kinetic parameters of left ventricle
    - Measurement of the effect of PDE5Ai on LV mass and on inter ventricular septum (IVS) at CMR at baseline and after PDE5Ai administration
    - Measurement of the effect of PDE5Ai on cardiac functional and performance parameters (EF, E/A, cardiac output) at CMR with tagging at baseline and after PDE5Ai administration
    - Evaluation of the effect of PDE5Ai on cardiac fibrosis measured by CMR T1-mapping in patients with Cushing Syndrome (CS) and related cardiomyopathy;
    - Evaluation of metabolic and neuroendocrine markers, pro-fibrotic and pro-inflammatory circulating chemokines related to the cardiomyopathy in CS;
    - Evaluation of new potential molecular markers (circulating miRNAs) related to the cardiomyopathy in CS;
    - Evaluation of the effect of PDE5Ai on body composition.
    - Misurazione dell'effetto dei PDE5Ai sullo strain del ventricolo sinistro alla CMR con tecnica tagging al baseline e dopo somministrazione dei PDE5Ai
    - misurazione degli effetti dei PDE5Ai sui parametri cinetici del ventricolo sinistro (VS)
    -misurazione degli effetti dei PDE5Ai sulla massa del VS e del setto interventricolare alla CMR al baseline e dopo somministrazione dei PDE5Ai
    - misurazione degli effetti dei PDE5Ai sulla funzionalità cardiaca e sui parametri di perfomance (EF, E/A, cardiac output) al CMR al baseline e dopo somministrazione dei PDE5Ai
    caratterizzazione della fibrosi cardiaca tramite T1 mapping
    - Misurare l'effetto sui marcatori metabolici e neuroendocrini, profibrotici e proinfiammatori e sulle chemochine circolanti
    - Valutazione di nuovi potenziali marker molecolari (miRNAs circolanti)
    - Valutazione dell'effetto dei PDE5Ai sulla composizione corporea
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age>18 yrs; patients (men and women) with previous diagnosis of CS, surgically and/or clinically treated according to current guidelines, with stable parameters of CS disease in the last 3 months, and with concomitant cardiac hypertrophy and/or diastolic dysfunction developed independently of CS care and detected by 2D echocardiography
    età> 18 anni; pazienti con precedente diagnosi di malattia di Cushing (CS) chirurgicamente e/o clinicamente trattata in accordo con le linee guida correnti, con parametri della CS stabili negli ultimi 3 mesi, e concomitante ipertrofia ventricolare sinistra e/o disfunzione diastolica sviluppata indipendentemente dalla CS e valutata all’ecocardiografia 2-d
    E.4Principal exclusion criteria
    congenital or valvular cardiomyopathy, recent ischemic heart disease or revascularization after a myocardical infarction (MI), and contraindications to tadalafil 20 mg use and to MRI examination
    Cardiomiopatie congenite o valvolari, recente infarto del miocardio o rivascolarizzazione dopo infarto del miocardio, controindicazioni all’uso del tadalafil (Cialis) e a sottoporsi alla Risonanza Magnetica.
    E.5 End points
    E.5.1Primary end point(s)
    Change of Left ventricular torsion (°)
    assessed through CMR with tagging before and after treatment
    Cambiamento della torsione (°) del ventricolo sinistro valutata tramite RMC con tagging prima e dopo il trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 5 months of treatment
    Dopo 5 mesi di trattamento
    E.5.2Secondary end point(s)
    1. Quantificazione della fibrosi miocardica con T1-mapping per stabilire nuovi parametri per la caratterizzazione della cardiomiopatica nella CS e gli effetti del trattamento, valutati tramite RMC prima e dopo il trattamento
    2. Assessment of cardiac remodeling and inflammatory indices, endothelial function markers, oxidative stress markers in monocytes, and correlation with cardiac parameters assessed through CMR
    3. Assessment of circulating microRNAs from plasma and white blood cells and correlation of their levels to basal torsion, strain and fibrosis
    4. Assessment of circulating microRNAs from plasma and white blood cells and correlation of their levels torsion, strain and fibrosis after treatment
    5. Assessment of circulating pro-fibrotic and pro-inflammatory chemokines (MCP-1 and TGF-beta) and correlation to torsion, strain and fibrosis at time 0 and after treatment
    6. Change of parameters of body composition evaluated by MOC with total body DEXA scan
    7. Change of cardiac strain (σ - longitudinal shortening: strain %), and of parameters of cardiac geometry and performance assessed through CMR with tagging before and after treatment
    1. Quantification of Myocardial fibrosis assessed with T1-mapping to estabilish new parameters for the carachterization of cardiomyophaty in CS and effects of the treatment, assessed through CMR before and after treatment
    2. Valutazione dei marcatori di rimodellamento cardiaco, infiammazione, funzione endoteliale e stress ossidativo nei monociti e correlazione con i parametri cardiaci misurati tramite RMC
    3. Valutazione dei microRNA circolanti da plasma e globuli bianchi e correlazione dei loro livelli con torsione, strain e fibrosi al basale
    4. Valutazione dei microRNA circolanti da plasma e globuli bianchi e correlazione dei loro livelli con torsione, strain e fibrosi dopo trattamento
    5. Valutazione delle chemochine circolanti pro-fibrotiche e pro-infiammatorie (MCP-1 e TGF-beta) e correlazione con torsione, strain e fibrosi al T0 e dopo trattamento
    6. VAriazione dei parametri di composizione corporea valutati tramite MOC con tecnica DEXA total body
    7. Cambiamento dello strain cardiaco (σ - accorciamento longitudinale in %), e dei parametri di geometria e performance cardiaca valutati tramite RMC con tagging prima e dopo il trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 5 months after treatment
    2. 5 months after treatment
    3. T0 before treatment
    4. 5 months after treatment
    5. Before (T0) and after treatment (5 months)
    6. 5 months after treatment
    7. 5 months after treatment
    1. 5 mesi dopo il trattamento
    2. 5 mesi dopo il trattamento
    3. T0 pre-trattamento
    4. 5 mesi dopo il trattamento
    5. Prima (T0) e dopo il trattamento (5 mesi)
    6. 5 mesi dopo il trattamento
    7. 5 mesi dopo il trattamento
    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 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 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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 15
    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)
    Follow-up as stated in the guidelines
    Follow-up come da linee guida per la patologia
    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 Decision2016-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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