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    The EU Clinical Trials Register currently displays   44257   clinical trials with a EudraCT protocol, of which   7344   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-004577-30
    Sponsor's Protocol Code Number:EARLY-GENE
    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:2021-12-22
    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 number2021-004577-30
    A.3Full title of the trial
    EARLY treatment with Candesartan vs Placebo in asymptomatic GENEtic carriers of Dilated Cardiomyopathy (EARLY-GENE trial)
    Inicio temprano de tratamiento con Candesartan vs Placebo en portadores genéticos de mutaciones causales de MCD sin evidencia de enfermedad (EARLY-GENE trial).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EARLY treatment with Candesartan vs Placebo in asymptomatic GENEtic carriers of Dilated Cardiomyopathy (EARLY-GENE trial)
    Inicio temprano de tratamiento con Candesartan vs Placebo en portadores genéticos de mutaciones causales de MCD sin evidencia de enfermedad (EARLY-GENE trial).
    A.3.2Name or abbreviated title of the trial where available
    EARLY-GENE
    EARLY-GENE
    A.4.1Sponsor's protocol code numberEARLY-GENE
    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 SponsorFUNDACION INVESTIGACION BIOMEDICA HOSPITAL PUERTA DE HIERRO MAJADAHONDA
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCReN - HOSPITAL PUERTA DE HIERRO MAJADAHONDA
    B.5.2Functional name of contact pointAna Velasco
    B.5.3 Address:
    B.5.3.1Street Addressc/ Joaquin Rodrigo 2
    B.5.3.2Town/ cityMajadahonda/Maadrid
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number34911917867
    B.5.6E-mailavelasco.idiphim@gmail.com
    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 Candesartán Kern Pharma 16 mg comprimidos EFG
    D.2.1.1.2Name of the Marketing Authorisation holderKERN PHARMA, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCANDESARTAN
    D.3.9.1CAS number 139481-59-7
    D.3.9.4EV Substance CodeSUB06070MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number16 to 32
    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 placeboBuccal tablet
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dilated Cardiomyopathy
    miocardiopatía dilatada
    E.1.1.1Medical condition in easily understood language
    Dilated Cardiomyopathy
    miocardiopatía dilatada
    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 assess if early administration of candesartan (compared to placebo) prevents either a significant Left ventricular ejection fraction (LVEF) decline of ≥10%, or a ventricular dilatation (left ventricular end-diastolic volume, LVEDV) increase of ≥10% in genetic carriers of a DCM-causing variant without disease expression.
    Estudiar si la administración precoz de candesartán (comparado con placebo) previene el deterioro significativo (≥10%) de la fracción de eyección del ventrículo izquierdo (FEVI) o la dilatación ventricular (volumen telediastólico ventricular izquierdo, VTDVI) en sujetos portadores genéticos de mutaciones causales de MCD sin expresión de la enfermedad.
    E.2.2Secondary objectives of the trial
    - To assess if early administration of candesartan (compared to placebo) reduces or prevents any sign of progression to DCM (LVEF decline, LVEDV increase, or LVEF<50%, assessed by MRI) in genetic carriers of a DCM-causing variant without disease expression.
    - To assess the safety and tolerability of candesartan (compared to placebo) in the study population.
    - Estudiar si la administración precoz de candesartán (comparado con placebo) reduce o previene signos de progresión a MCD (descenso de FEVI, aumento de VTDVI o aparición de FEVI<50%; evaluadas por resonancia magnética cardíaca (RMC)) en sujetos portadores genéticos de mutaciones causales de MCD sin expresión de la enfermedad.
    - Estudiar la seguridad y tolerabilidad del candesartán (comparado con placebo) en la población del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: 18-64 (both included), both sexes
    - Carrier of a pathogenic or likely pathogenic DCM genetic variant according to the modified American College of Medical Genetics (ACMG) criteria.
    - Baseline LVEF ≥ 50% measured by MRI evaluated by the eligibility study committee.
    - Baseline potassium ≤ 5.3 mEq/L, creatinine ≤ 1.3 mg/dL and an estimated Glomerular Filtration Rate (eGFR)≥ 60 ml/min/1.73 m2.
    - Able to understand and accept the study constraints and to provide informed consent (either by themselves or by a legal representative).
    - Edad: 18-64 (ambos incluidos), de ambos sexos.
    - Portadores de variantes patogénicas o probablemente patogénicas según criterios del American College of Medical Genetics (ACMG) en genes relacionados con MCD.
    - FEVI basal ≥ 50%, determinada por RMC y evaluada de forma centralizada.
    - Valores basales de potasio ≤ 5.3 mEq/L, creatinina ≤ 1.3 mg/dL y una Tasa de Filtrado Glomerular estimada (TFGe) ≥ 60 ml/min/1.73 m2.
    - Capacidad de comprender y aceptar las limitaciones del estudio y proporcionar un consentimiento informado (propio o a través de representante legal).
    E.4Principal exclusion criteria
    - Hypotension (systolic arterial pressure <100 mmHg)
    - Preexisting hypertension requiring pharmacological treatment.
    - Uncontrolled arterial hypertension (i.e., repeatedly systolic arterial pressure ≥ 140 mmHg)
    - Carriers of TTN-truncating variants (TTNtv) who are < 35 years old.
    - Known, clinically significant coronary artery disease (≥70% stenosis in any epicardial artery or ≥50% of left main coronary artery), valvular disease (≥ moderate in severity) or ventricular arrhythmias.
    - Ongoing treatment with ACE inhibitors, ARB, ARNI, MRA.
    - Prior intolerance to ACE inhibitors or ARB.
    - Presence of any contraindications to receive candesartan treatment, per investigator’s opinion.
    - Known bilateral renal artery stenosis.
    - Uncontrolled concomitant severe disease (e.g., with expected survival inferior to the duration of the study follow-up).
    - Participation in another clinical trial using an investigational medicinal product or device, in the 30 days prior to the inclusion in the study.
    - Current pregnancy, breastfeeding, or women of childbearing age who are not willing to practice an adequate birth control during the duration of the study (a negative pregnancy test result must be obtained at the time of enrolment).
    - Drug or alcohol abuse (current).
    - Inability to adequately comply with study procedures and treatments.
    - Carriers of MRI incompatible internal devices (pacemakers, aneurysm clips, etc.) or with known intolerance to MRI studies.
    - Any circumstances that in the investigator’s opinion compromise the participant’s ability to participate in the clinical trial.
    - Hipotensión, definida como presión arterial sistólica <100 mmHg.
    - Hipertensión arterial en tratamiento farmacológico preexistente.
    - Hipertensión arterial no controlada, definida como presión arterial sistólica ≥140 mmHg de forma repetida.
    - Portadores de variantes de truncamiento en titina (TTN) menores de 35 años.
    - Enfermedad arterial coronaria conocida y clínicamente significativa (estenosis de ≥70% en cualquier arteria epicárdica o de ≥50% en la arteria coronaria izquierda principal), enfermedad valvular (de gravedad moderada o superior) o arritmias ventriculares.
    - Tratamiento con inhibidores de la enzima convertidora de angiotensina (IECA), antagonistas de receptores de angiotensina II (ARA-II), antagonistas duales de receptor de angiotensina y neprilisina y antagonistas del receptor mineralcorticoide.
    - Intolerancia previa a IECA o ARA-II.
    - Cualquier contraindicación para el tratamiento con candesartán, según criterio del investigador.
    - Estenosis bilateral de la arteria renal conocida.
    - Enfermedad concomitante grave, no controlada (por ej., con supervivencia estimada menor a la duración del seguimiento del estudio).
    - Participación en otro ensayo con un medicamento o dispositivo en investigación dentro de los 30 días previos a la inclusión en el estudio.
    - Embarazo o lactancia actuales o planeados durante la duración del ensayo; así como mujeres en edad fértil no dispuestas a adoptar medidas anticonceptivas adecuadas durante todo el estudio (se requerirá test de embarazo negativo durante el reclutamiento).
    - Abuso de drogas o alcohol (actual).
    - Sospecha de cumplimiento deficiente del tratamiento o procedimientos del estudio.
    - Contraindicación de realización de RMC por dispositivo interno incompatible (marcapasos, clips de aneurismas…) o intolerancia conocida.
    - Cualquier circunstancia que a criterio del investigador pudiera comprometer la permanencia o cumplimiento del participante en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI.
    Proporción de participantes que progresan a un deterioro de ≥10% de FEVI o VTDVI, con respecto al valor inicial medido por RMC al final del seguimiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of follow-up (36 months)
    Al final del seguimiento (36 meses)
    E.5.2Secondary end point(s)
    - Proportion of participants that progress to a LVEF deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI.
    - Proportion of participants that progress to a LVEDV deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI.
    - Changes in LVEF measured by MRI (vs baseline)
    - Changes in LVEDV measured by MRI (vs baseline)
    - Proportion of individuals who develop DCM (LVEF<50%).
    - Proportion of participants in each treatment group developing Serious Adverse Events (SAEs), Grade 3-4 adverse events (AEs), Adverse Reactions, or AEs of Special Interest (AESIs).
    - Proportion of treatment discontinuations in the candesartan and placebo groups.
    - Proporción de participantes que progresan a un deterioro de FEVI ≥10% con respecto al valor inicial medido por RMC al final del seguimiento.
    - Proporción de participantes que progresan aun deterioro de VTDVI ≥10% con respecto al valor inicial medido por RMC al final del seguimiento.
    - Variación en FEVI al final del seguimiento respecto a la FEVI inicial, medida por RMC.
    - Variación en VTDVI al final del seguimiento respecto al VTDVI inicial, medido por RMC
    - Proporción de participantes que desarrollan MCD (FEVI<50%).
    - Proporción de participantes en cada grupo de tratamiento que desarrollan Eventos Adversos Graves (EAG), Eventos Adversos de grado 3-4 (AEs), reacciones adversas o Eventos Adversos de Especial Interés (EAEI).
    - Proporción de participantes que abandonan el tratamiento del estudio, en ambas ramas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of follow-up (36 months)
    Al final del seguimiento (36 meses)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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 concerned20
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 320
    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 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 state320
    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)
    The patient will receive the best available treatment, that the doctor considers the most appropriate for his/her situation, but the study medication will no longer be administered.
    El paciente recibirá el mejor tratamiento disponible, que su médico considere el más adecuado para su situación, pero no se le seguirá administrando la medicación del estudio.
    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 Decision2022-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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