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    Summary
    EudraCT Number:2015-004498-34
    Sponsor's Protocol Code Number:SUM
    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 number2015-004498-34
    A.3Full title of the trial
    Study on New Insights in Remodeling of Endocrine Cardiomyopathies: ASsessmentt of Intramyocardial, Molecular and NeUroendocrine Parameters in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in AcroMegaly - Endocrine cardiomyophaty: Response to cyclic GMP PDE5 inhibitors in Acromegaly cardiomyopathy
    “Analisi del Rimodellamento nelle cardiomiopatie endocrine: Valutazione Intramiocardica, Molecolare e Neuroendocrina in risposta all'Inibizione Cronica della GMP Ciclico-FoSfodiesterasi 5. Nuove IntUizioni sull’AcroMegalia” –
    Cardiomiopatia endocrina nell’acromegalia: risposta ai GMP ciclico PDE5 inibitori
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Endocrine cardiomyophaty: Response to cyclic GMP PDE5 inhibitors in Acromegaly cardiomyopathy
    Cardiomiopatia endocrina nell’acromegalia: risposta ai GMP ciclico PDE5 inibitori
    A.3.2Name or abbreviated title of the trial where available
    Endocrine cardiomyophaty: Response to cyclic GMP PDE5 inhibitors in Acromegaly cardiomyopathy
    Cardiomiopatia endocrina: risposta agli inibitori della PDE5 nella cardiomiopatia dell'Acromegalia
    A.4.1Sponsor's protocol code numberSUM
    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 propri
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Policlinico Umberto I / "Sapienza" Università di Roma
    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 code00126
    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
    Acromegaly
    Acromegalia
    E.1.1.1Medical condition in easily understood language
    Acromegaly
    Acromegalia
    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 10000599
    E.1.2Term Acromegaly
    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 remodeling (kinetic and geometry parameters) at cine cardiac magnetic resonance (CMR) with tagging technique
    and contrast-enhanced and at 2D echocardiography with Tissue Doppler Imaging and speckle tracking in patients with Acromegaly
    cardiomyopathy
    Valutazione degli effetti dei PDE5i sul rimodellamento cardiaco (geometria e cinetica) alla cine
    Risonanza Magnetica cardiaca con tecnica tagging e mezzo di contrasto e all’ Ecocardiografia 2-D con Tissue Doppler Imaging e
    tecnica speckle tracking in uomini e donne affetti da Acromegalia
    E.2.2Secondary objectives of the trial
    -to measure the effect of PDE5Ai on LV
    fibrosis at T1-mapping CMR at baseline and after PDE5Ai administration.
    -to measure the effect of PDE5Ai on cardiac performance at cine CMR and at 2D echocardiography with Tissue Doppler Imaging
    and speckle tracking at baseline and after PDE5Ai administration.
    -to measure the effect PDE5Ai of circulating cardiac-inflammatory-metabolic-endothelial molecular markers
    -to measure the effect on body composition
    - caratterizzazione della fibrosi cardiaca tramite T1 mapping prima e dopo trattamento con PDE5Ai
    - Misurare l’inotropismo e la contrattilità cardiaca tramite cardio RMN e ecocardiografia 2-D, Tissue Doppler Imaging e speckle
    tracking, prima e dopo trattamento
    - Misurare l'effetto sui marcatori molecolari infiammatori, metabolici ed endoteliali
    - misurare l'effetto 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 Acromegaly, surgically and/or clinically treated according to current
    guidelines, with stable parameters of Acromegaly disease in the last 3 months, and with concomitant cardiac hypertrophy and/or diastolic
    dysfunction developed independently of Acromegaly care and detected by 2D echocardiography
    età> 18 anni; pazienti con precedente diagnosi di Acromegalia chirurgicamente e/o clinicamente trattata in accordo
    con le linee guida correnti, con parametri dell'Acromegalia stabili negli ultimi 3 mesi, e concomitante ipertrofia ventricolare sinistra e/o
    disfunzione diastolica sviluppata indipendentemente dal trattamento dell'Acromegalia 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 (hypersensitivity to tadalafil, nitrates use, severe cardiovascular disorders (in the past 6 months) such as unstable angina or severe heart failure (NYHA II or III), or a stroke or myocardial infarction, heart rhythm problems, blood pressure <90/50 mmHg, severe hepatic or kidney impairment, and known hereditary degenerative retinal disorders such as retinitis pigmentosa, history of NAION)
    and to MRI examination
    - pregnant or lactating women
    Cardiomiopatie congenite o valvolari, recente infarto del miocardio o rivascolarizzazione dopo infarto del miocardio,
    controindicazioni all’uso del tadalafil 20 mg (ipersensibilità al tadalafil; uso di nitroderivati; patologie cardiovascolari gravi negli ultimi sei mesi come angina instabile o scompenso cardiaco grave, classe NYHA II o III, ictus, infarto del miocardio, aritmie cardiache, pressione arteriosa <90/50 mmHg, insufficienze epatiche o renali gravi, note patologie ereditarie degenerative della retina come la retinite pigmentosa, storia di NAION);
    e a sottoporsi alla Risonanza Magnetica.
    - donne in gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Change of Left ventricular torsion (°)
    assessed through CMR with tagging and 2D echocardiography before and after treatment
    Cambiamento della torsione (°) del ventricolo sinistro valutata tramite RMC con tagging e ecocardiografia 2D 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. Quantification of Myocardial fibrosis assessed with T1-mapping to estabilish new parameters for the carachterization of cardiomyophaty in Acromegaly and effects of the treatment, assessed through CMR before and after treatment
    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 and 2D
    echocardiography before and after treatment
    1. Quantificazione della fibrosi miocardica con T1-mapping per stabilire nuovi parametri per la caratterizzazione della cardiomiopatica nella Acromegalia e gli effetti del trattamento, valutati tramite RMC prima e dopo il trattamento
    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 e ecocardiografia 2D 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: 12
    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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