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    Summary
    EudraCT Number:2014-000077-39
    Sponsor's Protocol Code Number:RECOGITO_V1.0_2014
    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:2014-01-23
    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 number2014-000077-39
    A.3Full title of the trial
    Study on New Insights in Remodeling of Diabetic Cardiomyopathy: Gender Difference in Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A. - REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs (RECOGITO STUDY)
    Nuove Intuizioni sul Rimodellamento nella Cardiomiopatia Diabetica: Differenze di Genere nella valutazione Intramiocardica, Molecolare e Neuroendocrina in risposta all’Inibizione Cronica della GMP Ciclico-Fosfodiesterasi 5A. - RimodellamEnto nella CardiOmiopatia diabetica: differenze di Genere nella risposta ai pde5 InibiTOri – STUDIO RECOGITO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Differences between men and women in response to Phosphodiesterase 5 Inhibitors drugs in patients with diabetic cardiomyopathy
    Differenze tra uomini e donne nella risposta dei farmaci inibitori della Fosfodiesterasi 5 in pazienti affetti da cardiomiopatia diabetica
    A.3.2Name or abbreviated title of the trial where available
    RECOGITO Study
    Studio RECOGITO
    A.4.1Sponsor's protocol code numberRECOGITO_V1.0_2014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01803828
    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 SponsorSapienza University of Rome
    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 supportSapienza University of Rome
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSapienza University of Rome
    B.5.2Functional name of contact pointDpt of Experimental Medicine
    B.5.3 Address:
    B.5.3.1Street AddressViale Regina Elena 324
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number+390649970540
    B.5.5Fax number+390649970598
    B.5.6E-mailandrea.isidori@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
    D.2.1.1.2Name of the Marketing Authorisation holderLilly
    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 20 mg
    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 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 placeboTablet
    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
    Diabetic Cardiomyopathy, Diabetes Mellitus Type 2, Left Ventricular Hypertrophy
    Cardiopatia diabetica, Diabete mellito tipo 2, Ipertrofia Ventricolare Sinistra
    E.1.1.1Medical condition in easily understood language
    Diabetic Cardiomyopathy, Diabetes Mellitus, Cardiac Hypertrophy
    Cardiopatia diabetica, Diabete mellito, Ipertrofia cardiaca
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10049773
    E.1.2Term Left ventricular hypertrophy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10012647
    E.1.2Term Diabetic cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effect of PDE5Ai on cardiac remodeling measured by CMR in women and men with type 2 diabetes (T2DM).
    Valutare l'effetto degli inibitori della PDE5A sul rimodellamento cardiaco misurato con Risonanza Magnetica Cardiaca in donne e uomini affetti da diabete di tipo 2 (DM2).
    E.2.2Secondary objectives of the trial
    - Identify new molecular markers of DCM in the asymptomatic phase of the disease.
    - Identify new molecular markers that predict response to treatment with PDE5 inhibitors in DCM.
    - Identify gender differences in molecular and imaging characterization of the DCM.
    - Identify gender differences in response to treatment with PDE5 inhibitors in DCM.
    - Identificare nuovi marcatori molecolari di CMD nella fase asintomatica della malattia.
    - Identificare nuovi marcatori molecolari predittori di risposta al trattamento con inibitori della PDE5 nella CMD.
    - Identificare le differenze di genere nella caratterizzazione molecolare e di imaging della CMD.
    - Identificare le differenze di genere nella risposta al trattamento con inibitori della PDE5 nella DCM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 35-75 years,
    T2DM > 3 yrs,
    HbA1c < 10%,
    normal blood pressure or controlled hypertension;
    BMI < 40.

    Età 35-75 anni,
    Diabete mellito tipo 2 da almeno 3 anni,
    HbA1c < 10%,
    pressione arteriosa nella norma o ipertensione controllata,
    BMI < 40.
    E.4Principal exclusion criteria
    Congenital or valvular cardiomyopathy,
    ischemic heart disease,
    proliferative retinopathy,
    autonomic neuropathy;
    contraindications to tadalafil use or to CMR imaging.
    cardiopatia congenita o valvolare,
    cardiopatia ischemica,
    retinopatia proliferativa,
    neuropatia autonomica;
    controindicazioni all’uso di tadalafil o all’imaging con 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
    Modifiche nell'angolo di torsione ventricolare sinistra (°) valutata attraverso Risonanza Cardiaca con il tagging, prima e dopo il trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation at time 0 and after 5 months of treatment
    Valutazione al tempo 0 e dopo 5 mesi di trattamento
    E.5.2Secondary end point(s)
    - Change from baseline in longitudinal shortening (Strain %)
    - Change of cardiac strain (longitudinal shortening: strain %), and of parameters of cardiac geometry and performance assessed through CMR with tagging before and after treatment and gender differences

    - Change from baseline in Myocardial fibrosis
    - Quantification of Myocardial fibrosis assessed with T1-mapping to establish a new parametersfor the characterization of DCM and treatment efficacy, assessed through CMR before and after treatment and gender differences

    - Change from baseline in Circulating microRNAs
    - Assessment of circulating microRNAs from plasma and white blood cells (miR208, 499, 1, 133, 29, 223, 222) and correlation of their levels to basal torsion, strain and fibrosis (molecular markers predictors of disease).
    - Evaluation of miRNAs before and after treatment and and gender differences

    - Change from baseline in Circulating pro-fibrotic and pro-inflammatory chemokines
    - 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 (markers predictors of disease progression and treatment efficacy) and differences in genders

    - Markers predictor of answer to treatment
    - Correlation of basal miRNAs and chemokines to cardiac parameters assessed through CMR after treatment (markers predictor of answer to treatment) and differences in genders

    - Therapeutic efficacy markers
    - Changes of circulating miRNAs from plasma and whit blood cells (miR208, 499, 1, 133, 29, 223, 222), after treatment (therapeutic efficacy measure) and changes in circulating chemokines. These results will be related to changes measured in cardiac torsion, strain, fibrosis and geometry (CMR). Gender differences will be analyzed

    - Risk of progression to heart failure
    - Stratification of patients in subgroup with respect to kinetic parameters (strain and torsion), cardiac fibrosis, geometry (LV mass and index of concentricity) and performance and metabolic parameters to identify patients at risk of progression to heart failure and differences in genders
    E.5.2.1Timepoint(s) of evaluation of this end point
    CMR paramethers were evaluated at time 0 and after 5 months.
    Circulating pro-fibrotic and pro-inflammatory chemokines, miRNA and metabolic paramethers were evaluated before, after 3 and 5 months of treatment and 1 month after the end of treatment.
    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) 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 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 No
    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 years
    E.8.9.1In the Member State concerned months21
    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: 100
    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 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 state100
    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
    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 Decision2014-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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