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    Summary
    EudraCT Number:2019-002852-17
    Sponsor's Protocol Code Number:SSH-IC
    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:2020-03-06
    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 number2019-002852-17
    A.3Full title of the trial
    Efficacy and Safety of Intravenous Furosemide administered with Hypertonic Saline Solution at the Heart Failure Day Hospital. SSH-IC study
    Eficacia y Seguridad de la Furosemida Intravenosa administrada con Suero Salino Hipertónico en el Hospital de día de Insuficiencia Cardiaca. Estudio SSH-IC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of diuretic administered with saline solution in the patient who presents decompensation of heart failure and does not require hospitalization.
    Estudio de eficacia y seguridad de diurético administrado con solución salina en el paciente que presenta descompensación de insuficiencia cardiaca y no precisa ingreso hospitalario.
    A.3.2Name or abbreviated title of the trial where available
    SSH-IC trial
    Estudio SSH-IC
    A.4.1Sponsor's protocol code numberSSH-IC
    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 SponsorMarta Cobo Marcos
    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 Investigación Sanitaria Puerta de Hierro Majadahonda
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Puerta de Hierro Majadahonda
    B.5.2Functional name of contact pointUnidad Insuficiencia Cardiaca
    B.5.3 Address:
    B.5.3.1Street AddressCalle Manuel de Falla 2
    B.5.3.2Town/ cityMajadahonda
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number0034676743454
    B.5.6E-mailmartacobomarcos@hotmail.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 CLORURO DE SODIO B. BRAUN 20% CONCENTRADO PARA SOLUCION PARA PERFUSION
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical, S.A.
    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 Solution for infusion in administration system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM CHLORIDE SOLUTION 20%
    D.3.9.1CAS number 7440-23-5
    D.3.9.2Current sponsor code61987
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 20%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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
    Decompensated Heart Failure
    Insuficiencia Cardiaca Descompensada
    E.1.1.1Medical condition in easily understood language
    The heart doesn´t pump properly so there is fluid retention that causes shortness of breah and legs and abdomen swelling.
    Dificultad para respirar e hinchazón de piernas y abdomen por retención de líquidos debido a la incapacidad del corazón a bombear adecuadamente.
    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 LLT
    E.1.2Classification code 10010684
    E.1.2Term Congestive heart failure
    E.1.2System Organ Class 100000004849
    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 that the administration of intravenous furosemide associated with hypertonic saline solution is more effective than isolated furosemide in increase diuresis in the outpatient treatment of patients with congestive heart failure
    Demostrar que la administración de furosemida intravenosa asociada a suero salino hipertónico es más eficaz en incrementar la diuresis que la furosemida aislada en el tratamiento ambulatorio del paciente con descompensación de insuficiencia cardiaca congestiva.
    E.2.2Secondary objectives of the trial
    To compare both strategies in resolution of congestive data evaluated by physical examination, weight difference, biomarkers and imaging parameters (echocardioscopy)
    - Evaluate changes in renal function and serum ions and urine after administration of both treatments.
    - Assess adverse events during the first 7 and 30 days after treatment administration
    Need for new administration of intravenous diuretic in outpatient clinics or admission or emergency visit by heart failure
    Mortality or hospitalization due to heart failure
    Mortality or hospitalization for all causes.
    Worsening renal function: defined as creatinine increase ≥ 0.3 mg / dl
    Ionic alterations defined as hypokalemia less than 3.5 mEq / L or hyperkalemia greater than 5.5 mEq / L
    - Comparar ambas estrategias en resolución de datos congestivos evaluados mediante exploración física, diferencia de peso, biomarcadores y parámetros de imagen mediante ecocardioscopia.
    - Evaluar los cambios en la función renal e iones séricos y en orina tras la administración de ambos tratamientos.
    - Evaluar los eventos adversos durante los primeros 7 y 30 días tras la administración del tratamiento
    Necesidad de nueva administración de diurético intravenoso en hospital de día o ingreso o visita a urgencias por IC.
    Mortalidad u hospitalización por IC.
    Mortalidad u hospitalización por todas las causas.
    Empeoramiento de la función renal: definida como el incremento de creatinina ≥ de 0,3 mg/dl
    Alteraciones iónicas definidas como hipopotasemia menor de 3,5 mEq/L o hiperpotasemia mayor de 5,5 mEq/L
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age> 18 years
    • Previous diagnosis of HF and stable treatment the previous 4 weeks (except diuretic).
    • Basal treatment of at least 80 mg of furosemide daily.
    • Transthoracic echocardiogram performed last year. All ejection fraction (EF) groups are included.
    • Decompensated heart failure of congestive predominance. NTproBNP> 1000 pg / dL and the presence of at least two of the following congestion criteria will be required: Jugular pressuret> 10 cm, lower limb edema, ascites, or pleural effusion determined by chest x-ray or lung ultrasound.
    • Necessity at the discretion of the doctor responsible for intravenous diuretic to relieve congestion.
    • Edad > 18 años
    • Diagnóstico previo de IC y tratamiento estable las 4 semanas anteriores (excepto diurético).
    • Tratamiento basal al menos 80 mg de furosemida diarios.
    • Ecocardiograma transtorácico realizado el último año. Se incluyen todos los grupos de fracción de eyección (FE):
    • IC descompensada de predomino congestivo. Se requerirá NTproBNP > 1000 pg/dL y la presencia de al menos dos de los siguientes criterios de congestión: Ingurgitación yugular > 10 cm, edema de miembros inferiores, ascitis, o derrame pleural determinado por radiografía de tórax o ecografía pulmonar.
    • Necesidad a juicio del médico responsable de diurético intravenoso para alivio de la congestión.
    E.4Principal exclusion criteria
    - Hospital admission criteria in the opinion of the responsible physician.
    - Systolic blood pressure <90 mmHg or> 180 mmHg.
    - Heart rate> 150 bpm.
    - Basal oxygen saturation less than 90%.
    -Cardiogenic shock.
    -Acute Pulmonary Edema.
    - Clinically significant arrhythmia.
    - Acute myocardial ischemia.
    - Patients who are in a hemodialysis or peritoneal dialysis program.
    - Patients with serum sodium below <125 mEq / L or> 145 mEq / L or serum potassium below 3.5 mEq / L.
    - Hemoglobin less than 9 g / dL
    - Acute coronary syndrome or cardiological procedure in the previous 4 weeks.
    - Severe uncorrected valve disease except tricuspid regurgitation.
    - Moderate or severe dementia, active delirium or psychiatric problems that make the intervention difficult.

    - Patients in whom cardiac surgery or device implantation is planned in the following month
    - Pregnancy or breastfeeding
    - Inability to give informed consent in the absence of a legal officer.
    - Criterios de ingreso hospitalario a juicio del médico responsable.
    - Tensión arterial sistólica < 90 mmHg o > 180 mmHg.
    - Frecuencia cardiaca > 150 lpm.
    - Saturación oxígeno basal menor 90%.
    - Shock cardiogénico.
    - Edema agudo de pulmón.
    - Arritmia clínicamente significativa.
    - Isquemia miocárdica aguda.
    - Pacientes que se encuentren en programa de hemodiálisis o diálisis peritoneal.
    - Pacientes con sodio sérico por debajo de < 125 mEq/L o > 145 mEq/L o potasio sérico por debajo de 3,5 mEq/L.
    - Hemoglobina menor de 9 g/dL
    - Síndrome coronario agudo o procedimiento cardiológico en las 4 semanas anteriores.
    - Valvulopatía severa no corregida excepto la insuficiencia tricuspídea.
    - Demencia moderada o grave, delirium activo o problemas psiquiátricos que dificulten la intervención.

    - Pacientes en los que esté previsto cirugía cardíaca o implante de dispositivos en el siguiente mes
    - Embarazo o lactancia
    - Incapacidad para dar el consentimiento informado en la ausencia de un responsable legal.
    E.5 End points
    E.5.1Primary end point(s)
    Diuresis volume during the 3 hours after administration of intravenous furosemide associated with hypertonic saline versus diuresis volume after administration of isolated intravenous furosemide, in the patient with decompensated HF in the outpatient clinics.
    Volumen de diuresis durante las 3 horas posteriores a la administración de furosemida intravenosa asociada a suero salino hipertónico versus el volumen de diuresis tras la administración de furosemida intravenosa aislada, en el paciente con IC descompensada que acude al hospital de día de insuficiencia cardiaca.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 hours after the treatment administration.
    3 horas tras la administración de tratamiento.
    E.5.2Secondary end point(s)
    To compare both strategies in resolution of congestive data evaluated by physical examination, weight difference, biomarkers and imaging parameters (echocardioscopy)
    - Evaluate changes in renal function and serum ions and urine after administration of both treatments.
    - Assess adverse events during the first 7 and 30 days after treatment administration
    Need for new administration of intravenous diuretic in outpatient clinics or admission or emergency visit by heart failure
    Mortality or hospitalization due to heart failure
    Mortality or hospitalization for all causes.
    Worsening renal function: defined as creatinine increase ≥ 0.3 mg / dl
    Ionic alterations defined as hypokalemia less than 3.5 mEq / L or hyperkalemia greater than 5.5 mEq / L
    - Comparar ambas estrategias en resolución de datos congestivos evaluados mediante exploración física, diferencia de peso, biomarcadores y parámetros de imagen mediante ecocardioscopia.
    - Evaluar los cambios en la función renal e iones séricos y en orina tras la administración de ambos tratamientos.
    - Evaluar los eventos adversos durante los primeros 7 y 30 días tras la administración del tratamiento
    Necesidad de nueva administración de diurético intravenoso en hospital de día o ingreso o visita a urgencias por IC.
    Mortalidad u hospitalización por IC.
    Mortalidad u hospitalización por todas las causas.
    Empeoramiento de la función renal: definida como el incremento de creatinina ≥ de 0,3 mg/dl
    Alteraciones iónicas definidas como hipopotasemia menor de 3,5 mEq/L o hiperpotasemia mayor de 5,5 mEq/L
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week after treatment administration
    1 semana tras la administración del 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned13
    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
    Sample size obtained
    Haber alcanzado tamaño muestral
    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 months
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state168
    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)
    After administration of the study treatment, the outpatient oral diuretic treatment will be adjusted according to the pre-specified protocol based on usual practice.
    Tras la administración del tratamiento de estudio, el tratamiento diurético oral ambulatorio se ajustará según protocolo preespecificado basado en la práctica habitual.
    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 Decision2020-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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