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    Summary
    EudraCT Number:2015-004317-24
    Sponsor's Protocol Code Number:MN2015-1/A
    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:2021-09-09
    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 number2015-004317-24
    A.3Full title of the trial
    “A pilot study to assess Coronary Flow Reserve and post-vasodilatatory Myocardial Blood Flow (post-Dipi gMBF), measured by 13N-NH3 PET/CT, before and after a six months-long treatment with the ACE-inhibitor Perindopril, in moderate and high-risk HCM patients”
    A multicentric, interventional, open label, perspective-design, single-arm, “pilot” clinical Study.
    “A pilot study to assess Coronary Flow Reserve and post-vasodilatatory Myocardial Blood Flow (post-Dipi gMBF), measured by 13N-NH3 PET/CT, before and after a six months-long treatment with the ACE-inhibitor Perindopril, in moderate and high-risk HCM patients”
    A multicentric, interventional, open label, perspective-design, single-arm, “pilot” clinical Study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot-study to assess Coronary Flow reserve and post-vasodilation Myocardial Blood Flow , measured by PET with 13N-Ammonia, before and after a six-month long treatment with the ACE-Inhibitor Perindopril, in patients with moderate and high-risk Hypertrophic Cardiomyopathy"
    Uno Studio pilota per verificate la Riserva di Flusso Coronarico ed il Flusso Miocardico dopo vasodilatazione, misurate mediante PET con 13N-Ammonia, prima e dopo un periodo di trattamento di sei mesi con l'ACE-inibitore perindopril, in pazienti con Cardiomiopatia Ipertrofica a grado di rischio elevato o moderato"
    A.3.2Name or abbreviated title of the trial where available
    CARAPaCe (CoronAry Reserve After Perindopril in hypertophic Cardiomyopathy)
    CARAPaCe (CoronAry Reserve After Perindopril in hypertophic Cardiomyopathy)
    A.4.1Sponsor's protocol code numberMN2015-1/A
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
    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 supportministero della salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda ospedaliero-universitaria careggi
    B.5.2Functional name of contact pointSODC Medicina Nucleare- servizi inf
    B.5.3 Address:
    B.5.3.1Street Addresslargo Brambilla 3, 50134 firenze
    B.5.3.2Town/ cityfirenze
    B.5.3.3Post code50134
    B.5.3.4CountryItaly
    B.5.4Telephone number055 7946501
    B.5.5Fax number0557949684
    B.5.6E-mailroberto.sciagra@unifi.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 PROCAPTAN - 10 MG COMPRESSE RIVESTITE CON FILM 60 COMPRESSE IN CONTENITORE PER COMPRESSE PP
    D.2.1.1.2Name of the Marketing Authorisation holderIST.FARM.BIOL.STRODER S.R.L.
    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 nameprocaptan
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPERINDOPRIL ARGININA
    D.3.9.1CAS number 612548-45-5
    D.3.9.2Current sponsor code01
    D.3.9.3Other descriptive nameperindopril arginine
    D.3.9.4EV Substance CodeSUB23191
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 PROCAPTAN - 5 MG COMPRESSE RIVESTITE CON FILM 10 COMPRESSE IN CONTENITORE PER COMPRESSE PP
    D.2.1.1.2Name of the Marketing Authorisation holderIST.FARM.BIOL.STRODER S.R.L.
    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 nameprocaptan
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPERINDOPRIL ARGININA
    D.3.9.1CAS number 612548-45-5
    D.3.9.2Current sponsor code02
    D.3.9.3Other descriptive nameperindopril arginine
    D.3.9.4EV Substance CodeSUB23191
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Hypertrophic Cardiomyopathy (primitive)
    cardiomiopatia ipertrofica idiopatica
    E.1.1.1Medical condition in easily understood language
    Hypertrophy (increased mass and thickness) of the walls of the left ventricle, that determines phatophysiologic alterations of pump function of the heath, hischemia and arrhytmia; condition arises in
    ipertrofia (incremento della massa ed aumento dello spessore ) della pareti del ventricolo sinistro, cui conseguono alterazioni fisipatologiche della funzione di pompa cardiaca, ischemia ed aritmia; c
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020871
    E.1.2Term Hypertrophic cardiomyopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The comparison of global Myocardial Blood Flow g(MBF), after vasodilation by administration of Dipyridamole, (post-Dipi gMBF), measured by 13N-NH3 PET/CT, before and after a six month long treatment with Perindoprilarginine, in a sample of HCM patients belonging to moderate or high risk groups according to baseline post- Dipi gMBF <2.1 ml/min*gr.
    Comparazione del flusso miocardico globale post-vasodilatazione farmacologica con dipiridamolo (post-Dipi gMBF), misurato mediante 13N-NH3 PET/CT, prima e dopo un periodo di sei mesi di trattamento(*) con Perindopril-arginina, in un campione di pazienti con HCM classificati a rischio moderato od elevato in base al valore di post-Dipi gCBF di baseline (<2.1 ml/min*gr).
    E.2.2Secondary objectives of the trial
    The comparison of global Myocardial Blood Flow
    g(MBF) at rest before and after a six month long
    treatment with Perindopril-arginine, in a sample of
    HCM patients belonging to moderate or high risk
    groups according to baseline post-Dipi gMBF <2.1
    ml/min*gr.
    2- The comparison of Coronary Flow Reserve (CFR),
    before and after a six month-long treatment with
    Perindopril-arginine, in a sample of HCM patients
    belonging to moderate or high risk groups according
    to baseline post-Dipi gMBF <2.1 ml/min*gr.
    3- The assessment of safety of administration of
    Perindopril-arginine in a sample of HCM patients
    belonging to moderate or high risk groups according
    to baseline post-Dipi gMBF <2.1 ml/min*gr.
    1. Comparazione del flusso miocardico globale a riposo (rest gMBF), misurato mediante 13N-NH3 PET/CT, prima e dopo un periodo di sei mesi di trattamento con Perindopril-arginina in un campione di pazienti con HCM classificati a rischio moderato od elevato in base al valore di post-Dipi gMBF di baseline (<2.1 ml/min*gr).

    2. Comparazione del valore della riserva di flusso coronarico (CFR), prima e dopo un periodo di sei mesi di trattamento con Perindopril-arginina in un campione di pazienti con HCM classificati a rischio moderato od elevato in base al valore di post-Dipi gMBF di baseline (<2.1 ml/min*gr).

    3. Valutazione della sicurezza della somministrazione di Perindopril-arginina, in un campione di pazienti con HCM classificati a rischio moderato od elevato in base al valore di post-Dipi gMBF di baseline (<2.1 ml/min*gr).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age in the range 18-60
    2. Availability of a 12-lead rest-ECG, performed not
    earlier than 60 days prior to enrollment visit (EV).
    This is called B-ECG (Baseline-ECG), in the following
    text.
    3. Availability of a 2-D Doppler echocardiogram,
    performed at rest, not earlier than 60 days before of
    EV. This is called B-ECO (Baseline - Ecocardiography in the following text.
    4. Availability of a 13N-NH3 PET/CT myocardial
    perfusion scan for measurement of Myocardial Blood
    Flow (MBF), global and regional, performed not
    earlier than 60 days before of enrollment visit, at
    one or the other of involved clinical trial center. This
    is called B-PET/CT (Baseline-Positron Emission
    Tomography/Computed Tomography), in the
    following text
    5. Availability of lab tests (including at least:
    a. Hematocrit and complete blood count (CBC)
    b. blood urea nitrogen (BUN)
    c. serum creatinine,
    d. blood glucose,
    e. serum potassium ion
    performed not earlier than 60 days before of
    enrollment visit. This is called “Baseline-Blood Tests”
    (B-BT), in the following text.
    17
    6. Fulfillment of 2D-echocardiographyc (as assessed by
    B-ECO), and clinical criteria for diagnosis of HCM
    according to the ACCF/AHA Guideline (2011) for
    diagnosis of HCM:
    a. maximum LV wall thickness >1.5 cm
    b. not-dilated LV cavity
    in the absence of clinical evidence for any other
    cardiovascular or systemic etiology, justifying the
    degree of myocardial hypertrophy actually seen
    (e.g., arterial hypertension, aortic valve stenosis,
    cardiac amyloidosis, metabolic storage diseases, as
    detailed in the exclusion criteria).
    7. Absence of severe, resting LV outflow tract
    obstruction (peak gradient, measured at rest, >50
    mmHg), as assessed by B-ECO.
    8. Global Post-Dipi gMBF < 2.1 mL/min*gr, as assessed
    by 13N-NH3 PET/CT myocardial perfusion scan at
    baseline (B-PET/CT).
    9. Stable sinus rhythm, as assessed by B-ECG.
    10. Clear ability to understand the significance and the procedures of the Protocol and to sign a legally valid
    informed consent.
    1. Età compresa tra 18 e 60 anni
    2. Disponibilità di un ECG a 12 derivazioni a riposo, eseguito non più di 60 giorni prima della Visita di Arruolamento. Questo verrà indicato come “ECG di base” (B-ECG), nel testo seguente.
    3. Disponibilità di un ecocardiogramma Doppler 2D eseguito a riposo, non più di 60 giorni prima della Visita di Arruolamento. Questo verrà indicato come “ECO di base” (B-ECO), nel testo seguente.
    4. Disponibilità di una esame 13N-NH3 PET/CT per la misurazione del flusso miocardico (MBF), globale e regionale, eseguito a riposo e dopo vasodilatazione massimale dopo infusione di Dipiridamolo, non più di 60 giorni prima della Visita di Arruolamento, presso l’uno o l’altro dei due centri clinici coinvolti nel trial. Questo verrà indicato come “PET/CT di base” (B-PET/CT), nel testo seguente.
    5. Disponibilità di una serie di test di laboratorio, che includano almeno:
    a. emocromo con formula,
    b. azotemia,
    c. creatinina sierica,
    d. glicemia,
    e. potassiemia,
    eseguiti non più di 60 giorni prima della Visita di Arruolamento. Questi saranno indicati come “Esami Ematici di base” (B-BT, Baseline Blood Tests), nel testo seguente.
    6. Soddisfacimento dei criteri ecografici (da verificarsi su B-ECO) e clinici per la diagnosi di HCM secondo le linee guida 2011 ACCF/AHA:
    a. Spessore massimo della parete del VS, >1.5 cm
    b. Non dilatazione delle camere cardiache
    in assenza di evidenze cliniche per ogni altra causa, sistemica o locale, che possa giustificare il livello di ipertrofia osservato: per esempio, ipertensione arteriosa, stenosi della valvola aortica, amiloidosi cardiaca, malattie da accumulo metabolico, (vedi anche: criteri di esclusione).
    7. Assenza di significativa ostruzione del tratto di efflusso sistolico del VS (valore di picco di gradiente di efflusso sistolico a riposo <50 mmHg), verificato mediante B-ECO.
    8. Flusso coronarico globale post-Dipi (post-Dipi gMBF) inferiore a 2.1 ml/min*gr, verificato mediante la 13N-NH3 PET/CT di baseline (B-PET/CT
    9. Ritmo sinusale stabile, verificato mediante B-ECG.
    10. Chiara capacità di comprendere il significato dello Studio e le procedure del Protocollo, e di firmare un Consenso Informato legalmente valido.
    E.4Principal exclusion criteria
    1. Women, who are pregnant or lactating
    2. Women, i in childbearing age, not using an adequatecontraception (i.e., techniques having Pearl index<2)
    3. Clinical evidence or previous clinical story of diseasescausing myocardial hypertrophy or similar
    phenotypes:
    a. Aortic stenosis
    b. Cardiac amyloidosis
    c. hemochromatosis
    d. storage diseases
    4. Coronary Artery Disease :
    a. previous coronarography, assessing 1 or
    more stenosis >70% of major epicardial
    arteries
    b. Clinical story for previous PTCA
    c. Clinical story for previous CABG.
    5. Evidence for fixed or inducible regional defect of
    perfusion of LV, as assessed by B-PET/CT,
    suggesting CAD, unless recent (<30 days old)
    coronarography, negative for stenosis >70% in any
    of the major epicardial arteries, is available.
    6. Evidence for valvular heart disease (particularly for
    aortic stenosis), as assessed by B-ECO.
    7. Previous clinical story for arterial hypertension,
    requiring antihypertensive medication
    8. Arterial pressure >145 mmHg systolic and/or >90
    mmHg diastolic measured at EV
    9. Arterial pressure <110 mmHg systolic measured at EV (Enrollment Visit)
    10. LV outflow tract obstruction, with peak of ejection
    gradient >50 mmHg measured at rest, as assed by
    B-ECO
    11. Prior surgical septal myectomy or alcoholic ablation;
    12. LV systolic dysfunction with EF <50% as assessed
    by B-ECO.
    13. Evidence for electric ventricular conduction
    abnormalities such as LBBB, RBBB, WPW, AV blocks,Long QT, as assessed by B-ECG.
    14. Body mass index >32 Kg/m2
    15. Clinical evidence or clinical story for Diabetes
    Mellitus
    16. Clinical story for vasculitis or connective tissue
    disease (AR, LES, SS, MCTD, Churg Strauss
    vasculitis, ANCA-linked vasculitis, polyarterits
    nodosa, temporal arteritis, Takayasu disease, etc.)
    17. Clinical story for cancer of any kind unless nonmelanoma skin cancers
    18. GFR< 60 mL/min estimated by MDRD equation and by B-BT data.
    19. Clinical story for chronic liver disease with
    insufficiency > class A Child-Pugh
    20. Present evidence or previous story of neurologic
    diseases (cerebrovascular, neurodegenerative,
    demielinating)
    21. Clinical story for psychiatric disorders or
    administration (previous or present) of psychotropic
    drugs (unless minor tranquillizers or hypnotics)
    22. Clinical story for psychotropic drugs abuse or
    addiction, or for alcohol abuse/addiction
    23. Any contraindication to the administration of
    Perindopril,such as:
    a. Hypersensitivity to Perindopril or other
    ACE-inhibitors
    b. Clinical story for previous angioedema due
    to administration of ACE-inhibitors
    c. Clinical story for idiopathic or hereditary
    angioedema
    d. Aortic valve stenosis
    e. Mitral valve stenosis
    f. Liver failure > class A Child Pugh.
    g. GFR<60 ml/min, as estimated by MDRD
    equation and B-BT data
    h. LV outflow tract obstruction in HCM with
    peak of ejection gradient >50 mmHg
    measured at rest (assessed by B-ECO)
    i. Concurrent therapy with diuretics
    j. Concurrent therapy with potassium
    supplements or potassium sparing diuretics
    k. Concurrent therapy with lithium salts
    24. Any contraindication to the administration of
    Dipyridamole (Persantyn®), particularly:
    a. Individual hypersensitivity to the active
    substance or excipients of medicinal product
    b. Severe asthma
    25. Any contraindication to the administration of
    Aminophilline (Aminomal®), particularly:
    a. Individual hypersensitivity to the active
    substance or excipients of the medicinal
    product (Aminomal®)
    b. Individual hypersensitivity to other
    methylxanthines, and to lidocaine
    26. Any other serious medical condition, or comorbidity,
    severely impairing the physiological performance of
    the Subject, or that, at the judgment of the
    Investigator, may impair his/her compliance to the
    scheduled procedures and/or the completion of the
    Study, and/or the interpretation of scientific results
    27. Any other non-medical condition or situation,
    objective, subjective or logistic, to be assessed also
    in the judgment of the Investigator, which can
    impair the compliance of the Subject with the
    procedures scheduled by the Protocol and his/her
    participation in the Trial
    28. Subjects with previous exposure to ionizing radiation
    due to participation in clinical trials
    1. Donne in stato di gravidanza od in lattazione.
    2. Donne, in età fertile, che non utilizzino un adeguato sistema contraccettivo (cioè, tecniche con indice di Pearl <2).
    3. Evidenza clinica, o storia clinica, per malattie che possano causare ipertrofia cardiaca con fenotipo simile all’HCM:
    a. Stenosi aortica
    b. Amiloidosi cardiaca
    c. Emocromatosi
    d. Malattie da accumulo metabolico
    4. Evidenza per malattia delle arterie coronarie (CAD):
    a. precedente coronarografia che documenti la presenza di una o più stenosi >70% delle arterie coronarie epicardiche;
    b. precedente angioplastica (PTCA);
    c. precedente by-pass coronarico (CABG)).
    5. Evidenza per presenza di significativa ischemia regionale, fissa od inducibile, verificata mediante B-PET/CT, in difetto di disponibilità di una coronarografia recente (non anteriore a 30 giorni) che escluda la presenza di stenosi >70% delle arterie coronarie.
    6. Evidenza di malattia valvolare cardiaca (in particolare stenosi aortica), verificata mediante B-ECO.
    7. Storia clinica per ipertensione arteriosa cronica, in trattamento farmacologico.
    8. Pressione arteriosa >145 mmHg sistolica e/o >90 mmHg diastolica misurata alla Visita di Arruolamento.
    9. Pressione arteriosa < 110 mmHg sistolica misurata alla Visita di Arruolamento.
    10. Ostruzione del tratto di efflusso del VS con valore del picco di gradiente di efflusso sistolico a riposo >50 mmHg, verificata mediante B-ECO.
    11. Precedente miectomia chirurgica od ablazione alcolica del setto interventicolare.
    12. Disfunzione sistolica del VS, con frazione di eiezione <50%, verificata mediante B-ECO.
    13. Evidenza per difetti elettrofisiologici di conduzione (Blocco di branca destro, blocco di branca sinistro, emiblocchi, sindrome di Wolf-Parkinson White, blocchi atrio-ventricolari, sindrome QT lungo), verificata mediante B-ECG.
    14. Indice di massa corporea >32.
    15. Storia clinica di diabete mellito.
    16. Storia clinica per vasculiti o malattie del tessuto connettivo (es: artrite reumatoide, lupus eritematoso sistemico, sclerosi sistemica, malattia mista del tessuto connettivo, vasculite di Churg-Strauss, vasculiti ANCA-associate, poliartrite nodosa, arterite temporale, malattia di Takayasu, etc.)
    17. Neoplasie maligne di ogni tipo con eccezione per neoplasie cutanee non melanoma.
    18. GFR stimato <60 ml/min secondo l’equazione MDRD, applicata a dati di B-BT.
    19. Storia clinica per malattia epatica cronica con insufficienza epatica > classe A di Child-Pugh.
    20. Evidenza clinica o pregressa storia clinica per malattie neurologiche (cerebrovascolari, degenera-tive, demielinizzanti).
    21. Storia clinica per malattie psichiatriche o terapia (in corso o pregressa) con farmaci psicotropici, ad eccezione dei tranquillanti minori.
    22. Storia clinica per abuso/dipendenza da farmaci psicotropici, od abuso/dipendenza da alcoolici.
    23. Qualsiasi controindicazione alla somministrazione di Perindopril, quali:
    a. Ipersensibilità al Perindopril od altri ACE-inibitori.
    b. Storia clinica di angioedema associato a somministrazione di ACE-inibitori.
    c. Storia clinica per angioedema ereditario od idiopatico.
    d. Stenosi della valvola aortica.
    e. Stenosi della valvola mitralica.
    f. Insufficienza epatica di grado > classe A di Child Pugh.
    g. GFR <60 ml/min, stimato mediante equazione MDRD applicata a dati B-BT.
    h. Ostruzione del tratto di efflusso del VS con valore del picco del gradiente sistolico di ejezione a riposo >50 mmHg (verificata mediante B-ECO).
    i. Concomitante terapia con diuretici.
    j. Concomitante terapia con supplementi di potassio o con diuretici risparmiatori di potassio.
    k. Concomitante terapia con Sali di litio.
    24. Qualsiasi controindicazione alla somministrazione di Dipiridamolo (Persantin ®), in particolare:
    a. Ipersensibilità individuale accertata al principio attivo od agli eccipienti della specialità medicinale;
    b. Asma grave;
    25. Qualsiasi controindicazione alla somministrazione di aminofillina (Aminomal ®), in particolare:
    a. Ipersensibiltà individuale accertata alla sostanza attiva od agli eccipienti del prodotto medicinale;
    b. Ipersensibilità individuale accertata per altre metilxantine, ed alla lidocaina.
    26. Qualsiasi altra importante condizione clinica, o comorbillità, significativamente incidente sulla performance fisiologica del Soggetto, o che, a giudizio dello Sperimentatore, possa influire sulla compliance del Soggetto alle procedure previste dal Protocollo e sul completamento dello Studio, e/o pregiudicare la corretta interpretazione dei risultati scientifici.
    27. Qualsiasi altra condizione non-clinica, o situazione, oggettiva, soggettiva o logistica, da valutarsi anche a giudizio dello Sperimentatore, che possa influenzare negativamente la compliance del Soggetto per le procedure previste dal Protocollo e/o la sua partecipazione allo Studio.
    28. Pregressa esposizione a radiazioni ionizzanti a causa di partecipazione ad altri trials clinico-sperimentali.
    E.5 End points
    E.5.1Primary end point(s)
    Change of post-vasodilatation global Myocardial Blood Flow (post-Dipi gMBF), calculated as the difference between post-Dipi gMBF at the end of a six months-long treatment period with the ACE-inhibitor Perindopril-arginine and baseline values (measurements made by 13N-NH3 PET/CT)
    Variazione del flusso miocardico globale post-vasodilatazione (post-Dipi gMBF), calcolato come la differenza tra il post-Dipi gMBF dopo un periodo di 6 mesi di trattamento con l'ACE-inibitore Perindopril-arginina e i valori di baseline (misurazioni tramite 13N-NH3 PET/CT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    1-Change of Myocardial Blood Flow at rest (rest-gMBF), calculated as the difference between rest-gMBF at the end of a six months-long treatment period with the ACE-inhibitor Perindopril-arginine and baseline values (measurements made by 13N-NH3 PET/CT)

    2-Change of Coronary Flow reserve (CFR, i.e., ratio between post-Dipi gMBF and rest-gMBF), calculated as difference between CRF at the end of a six months-long treatment period with the ACE-inhibitor Perindopril-arginine and baseline values (measurements made by 13N-NH3 PET/CT)

    3-Recognition and classification of Adverse Events and Adverse Drug Reactions during treatment period with Perindopril-arginine.
    1- Variazione del flusso miocardico globale a riposo (rest-gMBF) calcolato come differenza tra il valore di flusso miocardico globale a riposo alla fine di un periodo di 6 mesi di trattamento con ACE-inibitore Perindopril-arginina ed i valori di baseline (misurazioni eseguite tramite 13N-NH3 PET/CT)
    2- Variazione della riserva di flusso coronarico (CFR; rapporto tra post-Dipi gMBF/rest gMBF) calcolata come differenza tra CFR alla fine del periodo di trattamento di 6 mesi con l'ACE-inibitore Perindopril-arginina e i valori di baseline (misurazioni eseguite tramite 13N-NH3 PET/CT)
    3- Riconoscimento e classificazione degli Eventi Avversi e delle reazioni avverse al farmaco durante il periodo di trattamento con Perindopril-arginina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 monyhs
    6 mesi
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    studio pilota
    pilot study
    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 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 concerned2
    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 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 years3
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days10
    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: 21
    F.1.3Elderly (>=65 years) No
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 21
    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)
    standard clinical care and therapy for the disease in object
    protocolli clinici standard di assistenza e terapia per la patologia in oggetto
    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 Decision2017-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-01
    P. End of Trial
    P.End of Trial StatusOngoing
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