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    Summary
    EudraCT Number:2017-002914-30
    Sponsor's Protocol Code Number:LCZ696-17
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-002914-30
    A.3Full title of the trial
    LCZ696 in heart failure patients with reduced ejection fraction and high comorbidity: effect on left ventricular remodeling and fibrosis assessed by novel heart failure biomarkers and cardiac magnetic resonance
    LCZ696 en pacientes con insuficiencia cardiaca con fracción de eyección reducida y alta comorbilidad: efecto en el remodelado ventricular izquierdo y fibrosis evaluados mediante nuevos biomarcadores de insuficiencia cardíaca y resonancia magnética cardíaca.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LCZ696 in heart failure patients: effect on left ventricular remodeling and fibrosis assessed by novel heart failure biomarkers and cardiac magnetic resonance
    LCZ696 en pacientes con insuficiencia cardiaca: efecto en el remodelado ventricular izquierdo y fibrosis evaluados mediante nuevos biomarcadores de insuficiencia cardíaca y resonancia magnética cardíaca.
    A.3.2Name or abbreviated title of the trial where available
    LCZ696-17 Study
    Estudio LCZ696-17
    A.4.1Sponsor's protocol code numberLCZ696-17
    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 SponsorFIMABIS
    B.1.3.4CountrySpain
    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 supportFIMABIS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS
    B.5.2Functional name of contact pointClinical Trial Platform
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Carlos Haya s/n, Pabellón A, 7 planta
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number+34951291977
    B.5.6E-mailgloria.luque@fimabis.org
    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 Entresto
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEntresto
    D.3.2Product code LCZ696
    D.3.4Pharmaceutical form 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 INNSacubitril
    D.3.9.1CAS number 149709-62-6
    D.3.9.3Other descriptive namesacubitril
    D.3.9.4EV Substance CodeSUB30457
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number97
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVALSARTAN
    D.3.9.1CAS number 137862-53-4
    D.3.9.3Other descriptive namevalsartan
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number103
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic heart failure NYHA class II-IV with reduced ejection fraction (EF =< 40%) and elevated NT-proBNP ≥ 600 pg/mL, but 400 pg/mL if hospitalized for heart failure within 12 months
    Insuficiencia cardiaca crónica NYHA clase II-IV con fracción de eyección reducida (EF = <40%) y elevada NT-proBNP ≥ 600 pg / mL, o NT-proBNP ≥ 400 pg / mL si el paciente ha sido hospitalizado por insuficiencia cardíaca en los últimos 12 meses.
    E.1.1.1Medical condition in easily understood language
    Chronic heart failure
    Insuficiencia cardíaca crónica
    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 describe the effect of LCZ696 on left ventricular remodeling and myocardial fibrosis assessed by cardiac magnetic resonance in heart failure patients with reduced ejection fraction and high comorbidity
    Describir el efecto de LCZ696 sobre la remodelación ventricular izquierda y la fibrosis miocárdica evaluada por resonancia magnética cardíaca en pacientes con insuficiencia cardíaca con fracción de eyección reducida y alta comorbilidad.
    E.2.2Secondary objectives of the trial
    - To describe the effect of LCZ696 on left ventricular remodeling and myocardial fibrosis assessed by novel heart failure biomarker (soluble ST2) in heart failure patients with reduced ejection fraction and high comorbidity.

    - To assess correlation of novel HF Biomarker with Soc HF biomarkers.

    - To describe the effect of LCZ696 on left ventricular remodeling and myocardial fibrosis assessed by variation from baseline in % of fibrosis and LV Volume
    - Describir efecto de LCZ696 sobre la remodelación del ventrículo izquierdo y la fibrosis miocárdica en pacientes con insuficiencia cardiaca con fracción de eyección reducida y alta comorbilidad, evaluados mediante biomarcadores específicos (ST2 soluble)

    - Evaluar la correlación entre los nuevos Biomarcadores HF y los Biomarcadores HF Soc.

    - Describir el efecto de LCZ696 sobre la remodelación del ventrículo izquierdo y la fibrosis miocárdica evaluado como variación del % de fibrosis y el Volumen del ventriculo Izquierdo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must give written informed consent before any assessment is performed.

    - Outpatients ≥ 18 years of age, male or female.

    -Diagnosis of chronic heart failure NYHA class II-IV with reduced ejection fraction (EF =< 40%) and elevated NT-proBNP ≥ 600 pg/mL, but 400 pg/mL if hospitalized for heart failure within 12 months.

    - Charlson Index ≥ 5.

    - The patients must be treated with angiotensin-converting-enzyme inhibitor (ACEI) or an angiotensin-converting-enzyme inhibitor (ARB), β-blocker and mineralocorticoid antagonist receptor unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
    - Los pacientes deben dar su consentimiento informado por escrito antes de realizar cualquier evaluación.
    - Pacientes ambulatorios ≥ 18 años de edad, hombres o mujeres.
    - Diagnóstico de insuficiencia cardiaca crónica NYHA clase II-IV con fracción de eyección reducida (EF = <40%) y elevada NT-proBNP ≥ 600 pg / mL, o 400 pg / mL si se hospitaliza por insuficiencia cardíaca en 12 meses.
    - Índice de Charlson ≥ 5.
    - Los pacientes deben ser tratados con un inhibidor de la enzima convertidora de la angiotensina (ACEI) o un inhibidor de la enzima convertidora de la angiotensina (ARB), un bloqueador β y un antagonista del receptor de mineralocorticoides, a menos que estén contraindicados o no tolerados, a una dosis estable durante al menos 4 semanas.
    E.4Principal exclusion criteria
    - History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or neprilysin inhibitors as well as known or suspected contraindications to the study drugs.

    - Previous history of intolerance to recommended target doses of ACEIs or ARBs.

    - Known history of angioedema.

    - Requirement of treatment with both ACEIs and ARBs

    - Current acute decompensated heart failure (exacerbation of chronic heart failure manifested by signs and symptoms that may require intravenous therapy).

    - Symptomatic hypotension and/or a SBP < 100 mmHg

    - Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) Study equation.

    - Serum potassium > 5.2 mmol/L.

    - Participation in clinical trial with another drug within 30 days of first study visit.
    - Historial de hipersensibilidad o alergia a cualquiera de los fármacos del estudio, fármacos de clases químicas similares, ACEI, ARB o inhibidores de la neprilisina, así como contraindicaciones conocidas o sospechadas de los fármacos del estudio.

    - Historial previo de intolerancia a las dosis objetivo recomendadas de ACEI o ARB.

    - Historia conocida de angioedema.

    - Requisito de tratamiento tanto con los ACEI como con los ARB.

    - Insuficiencia cardíaca descompensada aguda actual (exacerbación de insuficiencia cardíaca crónica manifestada por signos y síntomas que pueden requerir terapia intravenosa).

    - Hipotensión sintomática y / o TAS <100 mmHg

    - Estimación de la GFR <30 mL / min / 1,73m2, medida por la ecuación simplificada de Modificación de la Dieta en la Enfermedad Renal (MDER).

    - Potasio sérico> 5,2 mmol / L.

    - Participación en ensayos clínicos con otro fármaco dentro de los 30 días de la primera visita de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Variation of myocardial fibrosis assessed by changes (from basal to month 12 visit) in quantification of mass of myocardial fibrosis, as identified by delayed contrast-enhancement in cardiac MRI.
    - Variación de la fibrosis miocárdica evaluada por cambios (de la visita basal a la del mes 12) en la cuantificación de la masa de la fibrosis miocárdica, según se identifica por la disminución de la captación de contraste en la RM cardíaca.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Base line and after 12 months treatment
    Basal y tras 12 meses de tratamiento
    E.5.2Secondary end point(s)
    - Assessment of change from baseline in heart failure biomarkers: soluble ST2. Correlation with change in fibrosis as assessed by cardiac MRI.
    - Assessment of change from baseline in SoC heart failure biomarkers: (N- terminal pro-B-type natriuretic peptide and highly-sensitive troponin). Correlation with change assessed with novel biomarker.
    - Variation from baseline in percentage (%) of myocardial fibrosis and LV Volume according to total myocardium assessed by cardiac magnetic resonance.
    - Variación del biomarcador de insuficiencia cardíaca: ST2 soluble. Correlación con el cambio en la fibrosis determinada por RM cardiaca.
    - Variación del biomarcador de insuficiencia cardíacaSoC (péptido natriurético N-terminal tipo pro-B y troponina altamente sensible). Correlación con el cambio evaluado con el nuevo biomarcador (ST2 soluble).
    - Variación del porcentaje (%) de fibrosis miocárdica y del volumen de VI evaluado por resonancia magnética cardíaca.
    E.5.2.1Timepoint(s) of evaluation of this end point
    First two endpoints timepoint's: Baseline, 3, 6,9 and 12 months after treatment
    Third endpoint: Baseline and after 12 months treatment
    Primer y segundo endpoint: Basal y a los 3, 6, 9 y 12 meses de tratamiento.
    Tercer endpoint: Basal y tras 12 meses de tratamiento.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 No
    E.8.2.3Other No
    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 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
    UVUS
    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 months24
    E.8.9.1In the Member State concerned days21
    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: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 Information not present in EudraCT
    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 state68
    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)
    Patients will receive the most appropiate treatment available
    Los pacientes serán tratados con el mejor tratamiento disponible
    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 Decision2017-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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