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    Summary
    EudraCT Number:2011-001674-25
    Sponsor's Protocol Code Number:1684-H-295
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-28
    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 number2011-001674-25
    A.3Full title of the trial
    Evaluation of the efficacy of sildenafil on the functional capacity of patients with heart failure with preserved ejection fraction. A randomized, double blind, parallel group and placebo-controlled clinical trial.
    Evaluación de la eficacia del sildenafilo sobre la capacidad funcional de pacientes con insuficiencia cardíaca con fracción de eyección preservada. Ensayo clínico aleatorizado, doble ciego, de grupos paralelos y controlado con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy of sildenafil on the functional capacity of patients with heart failure with preserved ejection fraction. A randomized, double blind, parallel group and placebo-controlled clinical trial.
    Evaluación de la eficacia del sildenafilo sobre la capacidad funcional de pacientes con insuficiencia cardíaca con fracción de eyección preservada. Ensayo clínico aleatorizado, doble ciego, de grupos paralelos y controlado con placebo.
    A.3.2Name or abbreviated title of the trial where available
    SILICCON
    SILICCON
    A.4.1Sponsor's protocol code number1684-H-295
    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 SponsorFrancisco J. González Vílchez
    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 supportMinisterio de Sanidad, Política Social e Igualdad
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportCAIBER (Consorcio de Apoyo a la Investigación Biómédica en Red)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCAIBER (Consorcio de Apoyo a la Investigación Biómédica en Red)
    B.5.2Functional name of contact pointUCICEC H. U. Marqués de Valdecilla
    B.5.3 Address:
    B.5.3.1Street AddressEdificio IFIMAV. Avda Cardenal Herrera Oria s/n
    B.5.3.2Town/ citySantander
    B.5.3.3Post code39011
    B.5.3.4CountrySpain
    B.5.4Telephone number34942315515 ext. 73151
    B.5.5Fax number34942315517
    B.5.6E-mailifimav.eclinicos1@fmdv.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 Revatio 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNSILDENAFIL CITRATE
    D.3.9.1CAS number 171599-83-0
    D.3.9.3Other descriptive nameSILDENAFIL CITRATE
    D.3.9.4EV Substance CodeSUB04386MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboFilm-coated tablet
    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
    Heart failure with preserved ejection fraction.
    Insuficiencia cardíaca con fracción de eyección preservada.
    E.1.1.1Medical condition in easily understood language
    Heart failure with preserved ejection fraction.
    Insuficiencia cardíaca con fracción de eyección preservada.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10069211
    E.1.2Term Diastolic heart failure
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate an increase in the total distance walked in the six-minute walk test after 12 weeks of treatment with Sildenafil in patients with HFpEF.
    Demostrar un aumento en la distancia total recorrida en el test de los 6 minutos después de 12 semanas de tratamiento con Sildenafil en pacientes con ICFEP.
    E.2.2Secondary objectives of the trial
    1. To investigate the effect of prolonged oral therapy with Sildenafil on echocardiographic-derived parameters of cardiovascular function at rest and at exercise (cardiovascular reserve):
    a) Pulmonary artery pressure at rest and at exercise.
    b) Right ventricle function at rest and at exercise.
    c) Left ventricle systolic and diastolic function at rest and at exercise.
    d) Ventricular-vascular coupling at rest and at exercise.

    2. To correlate the increase in the total distance walked in the six-minute walk test and the changes in echocardiographic-derived parameters of cardiovascular function.

    3. To assess the effect of prolonged oral therapy with Sildenafil on the quality of life in patients with HFpEF, assessed by the score of the Minnesota Living with Heart Failure Questionnaire.
    1. Investigar el efecto del tratamiento prolongado por vía oral con Sildenafilo sobre parámetros ecocardiográficos de función cardiovascular en reposo y con el ejercicio (reserva cardiovascular):
    a) Presión arterial pulmonar en reposo y con el ejercicio.
    b) Función ventricular derecha en reposo y con el ejercicio.
    c) Función ventricular izquierda sistólica y diastólica en reposo y con el ejercicio.
    d) Acoplamiento ventrículo-arterial en reposo y con el ejercicio.

    2. Correlacionar el aumento en la distancia total recorrida en el ?test de los 6 minutos? y los cambios en los parámetros ecocardiográficos de función cardiovascular.

    3. Evaluar el efecto del tratamiento prolongado por vía oral con Sildenafilo sobre la calidad de vida de los pacientes con ICFEP, valorada mediante la puntuación del Minnesota Living with Heart Failure Questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 18 years.
    2. Previous diagnosis of heart failure by any of the following:
    - Criteria of Framingham.
    - Hospitalization for decompensated heart failure.
    - Long-term treatment with a loop diuretic and chronic diastolic dysfunction (left atrial enlargement by echocardiography).
    3. Current symptoms with functional class (NYHA) II-IV.
    4. Left ventricular ejection fraction > 50% by echocardiography whinthin the previous 3 months before study entry.
    5. Receiving stable medical therapy in the 30 days before study entry, as determined by no addition or removal of angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), beta-blockers, or calcium channel blockers (CCB) and no change in dosage of ACE, ARBs, beta-blockers, or CCBs of more than 100%.
    1. Edad > 18 años.
    2. Diagnóstico previo de insuficiencia cardiaca por cualquiera de los siguientes:
    - Criterios de Framingham.
    - Hospitalización por insuficiencia cardiaca descompensada.
    - Tratamiento crónico con un diurético de asa y disfunción diastólica crónica (crecimiento auricular izquierda por ecocardiografía).
    3. Síntomas actuales con clase funcional (NYHA) II-IV.
    4. Fracción de eyección ventricular izquierda > 50% por ecocardiografía dentro de los 3
    meses previos a la entrada en el estudio.
    5. Recibir tratamiento médico estable en los 30 días previos a la inclusión en el estudio:
    no adición o suspensión de inhibidores de la enzima convertidora de la angiotensina
    (IECA), bloqueantes del receptor de la angiotensina (ARA), beta-bloqueantes (BB), o antagonistas del calcio (AC) y no cambios mayores al 100% en las dosis de IECA, ARA, BB o AC.
    E.4Principal exclusion criteria
    1. Has a non-cardiac condition that prevents the subject from exercise testing or from walking in a hallway.
    2. Non-cardiac life expectancy < 1 year.
    3. Current or anticipated future need for nitrate therapy.
    4. Any valvular, pericardial o cardiomyopathy with specific therapy requirements.
    5. Acute coronary syndrome o coronary revascularization in the previous 6 months or expected need of coronary revascularization in the year after study entry.
    6. Any non-cardiac condition known to be associated with dyspnea (morbid obesity [Body mass index > 35 Kg/m2] or lung disease requiring oxygen or esteroids or FEV1 < 50% predicted or Epworth Sleepiness Scale > 20).
    7. Resting blood pressure < 110 / 40 mmHg or > 180 /100.
    8. Resting heart rate > 100 bpm.
    9. History of ejection fraction < 50%.
    10. Hb < 10 g/dL, severe renal disease (estimated glomerular filtration rate < 20 ml/min/1.73m2 g) or severe hepatic disease (aspartate aminotransferase level > 3 times the normal limit, alkaline phosphatase or bilirubin > 2 times the normal limit).
    11. Pregnant or not using an effective form of contraception.
    12. Taking nitrates, alpha antagonists, cytochrome P450 3A4 inhibitors/inducers, nicorandil, ranolazine or molsidain.
    13. Retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy, or unexplained visual disturbance.
    14. Sickle cell anemia, multiple myeloma, leukemia, or penile deformities that increase the risk for priapism (e.g., angulation, cavernosal fibrosis, Peyronie's disease).
    15. Severe cardiac ischemia in scintigraphy or echocardiography.
    16. Primary pulmonary arteriopathy.
    17. Inability or unwillingness of individual to give written informed consent.
    18. Participation in a clinical trial within the 6 months prior to the present study.
    19. History of allergy or intolerance to Sildenafil or other 5-Phosphodiesterase inhibitor.
    1. Ausencia de cualquier proceso que impida al sujeto la realización de ejercicio o caminar.
    2. Expectativa de vida por procesos no cardiacos < 1 año.
    3. Necesidad actual o prevista de tratamiento con nitratos.
    4. Cualquier enfermedad miocárdica, valvular o pericárdica que precise tratamiento específico.
    5. Síndrome coronario agudo o revascularización coronaria en los 6 meses previos a la inclusión en el estudio o previsión de la necesidad de revascularización coronaria en el año siguiente a la entrada en el estudio.
    6. Cualquier proceso no cardiaco que pueda asociarse a disnea (obesidad mórbida [Índice de masa corporal > 35 Kg/m2] o enfermedad broncopulmonar con precisión de oxígeno-terapia o esteroides o FEV1 < 50% de lo predicho o un puntuación en la escala de somnolencia de Epworth > 20).
    7. Presión arterial en reposo < 110 / 40 mmHg o > 180 /100 mmHg.
    8. Frecuencia cardiaca en reposo > 100 lpm.
    9. Historia de fracción de eyección ventricular izquierda < 50%.
    10. Hb < 10 g/dL, enfermedad renal grave (tasa de filtrado glomerular estimada < 20 ml/min/1.73m2 g) o enfermedad hepática grave (nivel de aspartato aminotransferasa > 3 veces el límite normal, fosfatasa alcalina o bilirrubina > 2 veces del límite normal).
    11. Embarazo o no usar un método efectivo de contracepción.
    12. Tomar nitratros, alfa-antagonistas, inhibidores/inductores del citocromo P450 3A4, nicorandil, ranolazina o molsidomina.
    13. Retinitis pigmentosa, diagnóstico previos de neuropatía óptica no isquémica, retinopatía proliferativa no tratada, o alteración visual no explicada.
    14. Anemia de células falciformes, mieloma múltiple, leucemia, o deformidades del pene con riesgo de priapismo (p.e., angulación, fibrosis cavernosa, enfermedad de Peyronie).
    15. Isquemia miocárdica severa en escintigrafía o ecocardiografía.
    16. Arteriopatía pulmonar primaria.
    17. Incapacidad o renuencia para otorgar un consentimiento informado por escrito.
    18. Participación en un ensayo clínico en los 6 meses previos al presente estudio.
    19. Historia de alergia o intolerancia al Sildenafilo u otro inhibidor de la 5-fosfodiesterasa.
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate an increase in the total distance walked in the six-minute walk test after 12 weeks of treatment with Sildenafil in patients with HFpEF.
    Demostrar un aumento en la distancia total recorrida en el test de los 6 minutos, después de 12 semanas de tratamiento con Sildenafilo en pacientes con ICFEP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    1. To investigate the effect of prolonged oral therapy with Sildenafil on echocardiographic-derived parameters of cardiovascular function at rest and at exercise (cardiovascular reserve):
    a) Pulmonary artery pressure at rest and at exercise.
    b) Right ventricle function at rest and at exercise.
    c) Left ventricle systolic and diastolic function at rest and at exercise.
    d) Ventricular-vascular coupling at rest and at exercise.

    2. To correlate the increase in the total distance walked in the six-minute walk test and the changes in echocardiographic-derived parameters of cardiovascular function.

    3. To assess the effect of prolonged oral therapy with Sildenafil on the quality of life in patients with HFpEF, assessed by the score of the Minnesota Living with Heart Failure Questionnaire.
    1. Investigar el efecto del tratamiento prolongado por vía oral con Sildenafilo sobre parámetros ecocardiográficos de función cardiovascular en reposo y con el ejercicio (reserva cardiovascular):
    a) Presión arterial pulmonar en reposo y con el ejercicio.
    b) Función ventricular derecha en reposo y con el ejercicio.
    c) Función ventricular izquierda sistólica y diastólica en reposo y con el ejercicio.
    d) Acoplamiento ventrículo-arterial en reposo y con el ejercicio.

    2. Correlacionar el aumento en la distancia total recorrida en el ?test de los 6 minutos? y los cambios en los parámetros ecocardiográficos de función cardiovascular.

    3. Evaluar el efecto del tratamiento prolongado por vía oral con Sildenafilo sobre la calidad de vida de los pacientes con ICFEP, valorada mediante la puntuación del Minnesota Living with Heart Failure Questionnaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    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 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 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 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
    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 months3
    E.8.9.1In the Member State concerned days14
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly people (> 65 years old)
    Población mayor de 65 años
    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)
    There is planned a 2 week follow-up within the study, afterwards the patientes will be given the usual treatment
    Patients will receive the most appropriate treatment for their disease according to routine clinical practice and will be followed up according to the routine practice in patients with the same disease.
    Los pacientes recibirán el tratamiento más adecuado para su enfermedad según la práctica clínica habitual y se les realizará el seguimiento habitual en los pacientes con su misma enfermedad.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-07-12
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